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Seysara sarecycline hydrochloride 100 mg Tablet, Coated, 30-count — NDC 16110-0246-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Seysara sarecycline hydrochloride 100 mg Tablet, Coated, 30-count — NDC 16110-246-30 (Billing 16110-0246-30)

by Almirall, LLC · 30 TABLET, COATED in 1 BOTTLE

This is a package of 30 tablets of Seysara sarecycline hydrochloride 100 mg Tablet, Coated from Almirall, LLC, marketed since Jan 2019 and currently FDA-listed.

NDC 16110-0246-30
🏷️ FDA NDC (as labeled) 16110-246-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also priced by: Part D plans $36.94/unit — full pricing hub ↓
Product page 16110-0246-00 Also comes in: 29000 tablets 16110-246-00
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 16110-246-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
16110 labeler · 246 product · 30 package
Listing certified through
Dec 31, 2027
Billing quantity
30 EA per package
Barcode (UPC)
0316110245300, 0316110246307
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 16110-246-30
Product NDC 16110-246
11-digit billing NDC 16110024630
NCPDP billing unit EA — each (per item)
RxCUI 2059023, 2059029, 2059031, 2059033, 2059035, 2059037
UNII 36718856JR
UPC 0316110245300, 0316110246307
Application # NDA209521
SPL Set ID b200957c-3004-4988-be97-9fd619a83649
Established class (EPC) Tetracycline-class Drug
Mechanism of action P-Glycoprotein Inhibitors
Chemical class Tetracyclines
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-01-04
Route ORAL
Dosage form TABLET, COATED
Substance SARECYCLINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 04000057100330
GPI class Seysara
GCN Seq No 079079
GCN 45511
HICL code 045331
Ingredient (HICL) Sarecycline Hcl
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1C
Therapeutic class — specific (HIC3) Tetracycline Antibiotics
AHFS code 08:12.24.04
AHFS class Aminomethylcyclines
FDB label name SEYSARA 100 MG TABLET
FDB brand name Seysara
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 079079
  • GCN: 45511
  • GPI-14 (Medi-Span): 04000057100330
  • HICL (First Databank): 045331
  • AHFS class code: 08:12.24.04
  • RxCUI (RxNorm): 2059023
Why two NDCs? The FDA registers this code as 16110-246-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 16110-0246-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Tetracycline-class Drug class.

Pharmacologic class Tetracycline-class Drug
Drug family (ATC) Tetracyclines
How it works P-Glycoprotein Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name SEYSARA 100 MG TABLET Ingredient Sarecycline Hcl
📗 Our plain-language guide HelloPharmacist
  • It treats the inflamed pimples of moderate to severe non-nodular acne vulgaris in people 9 and older. It is not meant for treating infections. Use it only as prescribed so the anti...
  • Take one tablet by mouth once a day, with or without food. Drink a full glass of water to help prevent irritation of your esophagus. Follow your prescriber's directions, and expect...
  • Nausea was the most common one in studies. Some women had vaginal yeast infections. Call your doctor if you get vision changes, bad headaches, or diarrhea that won't go away.
  • Yes. This medicine can make you sunburn more easily. Avoid tanning beds and UV treatments, wear loose, protective clothing outdoors, and ask about other sun protection.
📖 Read our full Sarecycline guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $36.94 $1,108.14 / 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
16110-0246-30 You're viewing this 30 TABLET, COATED in 1 BOTTLE 2019-01-04 — Active
16110-0246-00 16110-246-00 Main listing 29000 TABLET, COATED in 1 BAG — — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 tablet, coated in 1 bottle.
How does this package differ from NDC 16110-0246-00?
Both are Seysara sarecycline hydrochloride 100 mg Tablet, Coated — the drug itself is identical. This page's package is the 30-count one, while NDC 16110-0246-00 is the 29000 tablets package.
What NDC number is used to bill for this package of Seysara sarecycline hydrochloride 100 mg Tablet, Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Seysara 100 mgthis 16110-0246-30 Almirall, 30 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2018
First FDA approval
Oct 2018
📍
2026
Currently FDA-listed
8 years listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 1, 2018 RLD RS ⏳ ~6.3 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8513223 — method of use (U-2406)
US 9481639 — method of use (U-2409)
US 8318706 — drug substance (U-2405)
US 9481639 — method of use (U-2409)
US 9481639 — method of use (U-2409)
US 9255068 — drug substance (U-2407)
US 8318706 — drug substance (U-2405)
US 8513223 — method of use (U-2406)
US 9255068 — drug substance (U-2408)
US 8318706 — drug substance (U-2405)
US 9255068 — drug substance (U-2408)
US 9255068 — drug substance (U-2407)
US 9255068 — drug substance (U-2408)
US 8513223 — method of use (U-2406)
US 9255068 — drug substance (U-2407)
2018 2020 2022 2024 2026 2028 2030 2032
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (15)
PatentTypeUse codeExpires
US 8513223 ↗ Method of use U-2406 Dec 7, 2029
US 9481639 ↗ Method of use U-2409 Aug 10, 2028
US 8318706 ↗ Drug substance U-2405 Jan 3, 2032
US 9481639 ↗ Method of use U-2409 Aug 10, 2028
US 9481639 ↗ Method of use U-2409 Aug 10, 2028
US 9255068 ↗ Drug substance U-2407 Feb 9, 2033
US 8318706 ↗ Drug substance U-2405 Jan 3, 2032
US 8513223 ↗ Method of use U-2406 Dec 7, 2029
US 9255068 ↗ Drug substance U-2408 Feb 9, 2033
US 8318706 ↗ Drug substance U-2405 Jan 3, 2032
US 9255068 ↗ Drug substance U-2408 Feb 9, 2033
US 9255068 ↗ Drug substance U-2407 Feb 9, 2033
US 9255068 ↗ Drug substance U-2408 Feb 9, 2033
US 8513223 ↗ Method of use U-2406 Dec 7, 2029
US 9255068 ↗ Drug substance U-2407 Feb 9, 2033
Common questions
Is there a generic version of SEYSARA 100 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for SEYSARA 100 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2033 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Yellow
ShapeCapsule
ImprintS150
Size17 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Sarecycline inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAlmirall, LLC
Application holderALMIRALL LLC
FDA applicationNDA209521 (NDA)
Labeler code16110
First marketedJan 2019
Product typeHuman Prescription Drug
Portfolio11 products on file

More NDCs from Almirall, LLC labeler code 16110

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 190 words ▾

1 INDICATIONS AND USAGE SEYSARA ® (sarecycline) tablet, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Limitations of Use Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established. SEYSARA has not been evaluated in the treatment of infections [see Clinical Studies ( 14 )] .

To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SEYSARA should be used only as indicated [see Warnings and Precautions ( 5.6 )] . SEYSARA ® is a tetracycline-class drug indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. ( 1 ) Limitations of Use Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established.

SEYSARA has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SEYSARA should be used only as indicated [see Warnings and Precautions ( 5.6 )].

⏱️ Dosage and Administration 126 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of SEYSARA is based on body weight described in Table 1 . If there is no improvement after 12 weeks, reassess treatment with SEYSARA. Table 1: Dosing Table for SEYSARA Body Weight (kg) Tablet Strength 33 to 54 kg 60 mg tablet 55 to 84 kg 100 mg tablet 85 to 136 kg 150 mg tablet Take SEYSARA once daily, with or without food.

To reduce the risk of esophageal irritation and ulceration, administer SEYSARA with adequate amounts of fluid. The recommended dosage of SEYSARA is once daily with or without food ( 2 ): 60 mg for patients who weigh 33-54 kg, 100 mg for patients who weigh 55-84 kg, 150 mg for patients who weigh 85-136 kg.

💊 Dosage Forms and Strengths 72 words ▾

3 DOSAGE FORMS AND STRENGTHS SEYSARA (sarecycline) tablets: 60 mg: capsule-shaped, yellow, film-coated tablets debossed with “S60” on one side and blank on the other side. 100 mg: capsule-shaped, yellow, film-coated tablets debossed with “S100” on one side and blank on the other side. 150 mg: capsule-shaped, yellow, film-coated tablets debossed with “S150” on one side and blank on the other side. Tablets: 60 mg, 100 mg, 150 mg ( 3 )

⛔ Contraindications 33 words ▾

4 CONTRAINDICATIONS SEYSARA is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. SEYSARA is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS The use of SEYSARA during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). ( 5.1 ) If Clostridium difficile Associated Diarrhea (antibiotic associated colitis) occurs, discontinue SEYSARA. ( 5.2 ) Central nervous system side effects, including light-headedness, dizziness or vertigo, have been reported with tetracycline use.

Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery. These symptoms may disappear during therapy and may disappear when the drug is discontinued. ( 5.3 ) SEYSARA may cause intracranial hypertension.

Discontinue SEYSARA if symptoms occur. ( 5.4 ) Photosensitivity can occur with SEYSARA. Patients should minimize or avoid exposure to natural or artificial sunlight.

( 5.5 )

5.1Teratogenic Effects SEYSARA, like other tetracyclines, can cause fetal harm when administered to a pregnant woman. If SEYSARA is used during pregnancy or if the patient becomes pregnant while taking SEYSARA, the patient should be informed of the potential hazard to the fetus and treatment should be stopped immediately. The use of drugs of the tetracycline-class during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown).

This adverse reaction is more common during long-term use of these drugs, but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. All tetracyclines form a stable calcium complex in any bone-forming tissue.

A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus.

Evidence of embryotoxicity has been noted in animals treated with SEYSARA during pregnancy in association with maternal toxicity [see Use in Specific Populations ( 8.1 )] .

5.2Clostridium difficile Associated Diarrhea (Antibiotic Associated Colitis) Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to potential overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile should be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

5.3Central Nervous System Effects Central nervous system side effects including light-headedness, dizziness or vertigo have been reported with tetracycline use. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery. These symptoms may disappear during therapy and may disappear when the drug is discontinued.

5.4Intracranial Hypertension Intracranial hypertension in adults and adolescents has been associated with the use of tetracyclines. Clinical manifestations include headache, blurred vision and pap… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 150 words ▾

6 ADVERSE REACTIONS Most common adverse reaction (incidence ≥ 1%) is nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Almirall at 1-866-665-2782 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 1064 subjects and 1069 subjects with moderate to severe acne vulgaris were treated with SEYSARA and placebo, respectively, for 12 weeks in 3 controlled clinical trials. The only adverse drug reaction that was reported in at least 1% of subjects was nausea, SEYSARA (3.1%) versus placebo (2.0%).

The following additional adverse drug reactions occurred in less than 1% of female SEYSARA subjects: vulvovaginal mycotic infection (0.8%) and vulvovaginal candidiasis (0.6%).

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Oral retinoids: avoid coadministration. ( 5.4 , 7.1 ) Antacids and iron preparations: separate dosing of SEYSARA. ( 7.1 ) Penicillin: avoid coadministration. ( 7.2 ) Anticoagulants: decrease anticoagulant dosage as appropriate. ( 7.2 ) P-glycoprotein substrates: monitor for toxicities of drugs that may require dosage reduction. ( 7.2 )

7.1Effect of Other Drugs on SEYSARA Oral Retinoids Tetracyclines may cause increased intracranial pressure as do oral retinoids, including isotretinoin and acitretin [see Warnings and Precautions ( 5.4 )] . Avoid coadministration of SEYSARA with oral retinoids. Antacids and Iron Preparations Coadministration with antacids containing aluminum, calcium or magnesium, bismuth subsalicylate, and iron-containing preparations may impair absorption of SEYSARA, similar to other tetracyclines, which may decrease its efficacy.

Separate dosing of SEYSARA from antacids containing aluminum, calcium or magnesium, bismuth subsalicylate, and iron-containing preparations.

7.2Effect of SEYSARA on Other Drugs Penicillin Similar to other tetracyclines, SEYSARA may interfere with the bactericidal action of penicillin. Avoid coadministration of SEYSARA with penicillin. Anticoagulants Similar to other tetracyclines, SEYSARA may depress plasma prothrombin activity, which may increase the risk of bleeding in patients who are on anticoagulant therapy.

Decrease anticoagulant dosage when coadministered with SEYSARA as appropriate. P-Glycoprotein (P-gp) Substrates Concomitant use of SEYSARA may increase concentrations of concomitantly administered P-gp substrates (e.g. digoxin). Monitor for toxicities of drugs that are P-gp substrates and may require dosage reduction when given concurrently with SEYSARA [see Clinical Pharmacology ( 12.3 )] .

Oral Hormonal Contraceptives There is no clinically significant effect of SEYSARA on the efficacy of oral contraceptives containing ethinyl estradiol and norethindrone acetate [see Clinical Pharmacology ( 12.3 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Sarecycline, like other tetracycline-class drugs, can cause fetal harm when administered to a pregnant woman. ( 5.1 , 8.1 ) The use of drugs of the tetracycline class during tooth development may cause permanent discoloration of teeth. ( 5.1 , 8.4 ) Lactation: Breastfeeding is not recommended. ( 8.2 )

8.1Pregnancy Risk Summary SEYSARA, like tetracycline class drugs, may cause fetal harm, permanent discoloration of teeth, and reversible inhibition of bone growth when administered during pregnancy [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )] . The limited available human data are not sufficient to inform a drug-associated risk for birth defects or miscarriage. Tetracyclines are known to cross the placental barrier; therefore, SEYSARA may be transmitted from the mother to the developing fetus.

In animal reproduction studies, sarecycline induced skeletal malformations in fetuses when orally administered to pregnant rats during the period of organogenesis at a dose 1.4 times the maximum recommended human dose (MRHD) of 150 mg/day (based on AUC comparison). When dosing with sarecycline continued through the period of lactation, decreases in offspring survival, offspring body weight, and implantation sites and viable embryos in offspring females occurred at a dose 3 times the MRHD (based on AUC comparison) [see Data ] .

The potential risk to the fetus outweighs the potential benefit to the mother from SEYSARA use during pregnancy; therefore, pregnant patients should discontinue SEYSARA as soon as pregnancy is recognized. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryofetal developmental study in rats, sarecycline was administered to pregnant rats at oral doses up to 500 mg/kg/day during the period of organogenesis. Decreases in maternal body weight, fetal body weight and litter size and increases in the number of resorption and postimplantation loss occurred at 500 mg/kg/day (7 times the MRHD based on AUC comparison).

Skeletal malformations (bent forelimb, hindlimb, and scapula) occurred at all dose levels (≥ 50 mg/kg/day, 1.4 times the MRHD based on AUC comparison). In an embryofetal developmental study in rabbits, sarecycline was administered to pregnant rabbits at oral doses up to 150 mg/kg/day during the period of organogenesis. Excessive maternal toxicity (mortality/moribundity/abortion) occurred at 150 mg/kg/day (5 times the MRHD based on AUC comparison) and this dose group was terminated early.

Maternal moribundity also occurred at 100 mg/kg/day (0.6 times the MRHD based on AUC comparison). No significant embryofetal toxicity or malformations were observed at doses up to 100 mg/kg/day (0.6 times the MRHD based on AUC comparison). In a pre- and post-natal developmental study in rats, sarecycline was administered to maternal rats at oral doses up to 400 mg/kg/day during the period of organogenesis through lactation.

Excessive litter toxicity (litter loss and stillbirth) occurred at 400 mg/kg/day (8 times the MRHD based on AUC comparison), which led to early termination of dams at parturition. Decreases in body weight and food consumption of dams during the lactation period occurred at 150 mg/kg/day (3 times the MRHD based on AUC comparison). Decreases in offspring survival and offspring body weight during the preweaning and growth period, and decreases in implantation sites and viable embryos in female offspring occurred at 150 mg/kg/day (3 times the MRHD based on AUC comparison).

No significant maternal or developmental toxicity was observed at 50 mg/kg/day (1.4 times the MRHD based on AUC comparison).

8.2Lactation Ris… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary SEYSARA, like tetracycline class drugs, may cause fetal harm, permanent discoloration of teeth, and reversible inhibition of bone growth when administered during pregnancy [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )] . The limited available human data are not sufficient to inform a drug-associated risk for birth defects or miscarriage. Tetracyclines are known to cross the placental barrier; therefore, SEYSARA may be transmitted from the mother to the developing fetus.

In animal reproduction studies, sarecycline induced skeletal malformations in fetuses when orally administered to pregnant rats during the period of organogenesis at a dose 1.4 times the maximum recommended human dose (MRHD) of 150 mg/day (based on AUC comparison). When dosing with sarecycline continued through the period of lactation, decreases in offspring survival, offspring body weight, and implantation sites and viable embryos in offspring females occurred at a dose 3 times the MRHD (based on AUC comparison) [see Data ] .

The potential risk to the fetus outweighs the potential benefit to the mother from SEYSARA use during pregnancy; therefore, pregnant patients should discontinue SEYSARA as soon as pregnancy is recognized. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryofetal developmental study in rats, sarecycline was administered to pregnant rats at oral doses up to 500 mg/kg/day during the period of organogenesis. Decreases in maternal body weight, fetal body weight and litter size and increases in the number of resorption and postimplantation loss occurred at 500 mg/kg/day (7 times the MRHD based on AUC comparison).

Skeletal malformations (bent forelimb, hindlimb, and scapula) occurred at all dose levels (≥ 50 mg/kg/day, 1.4 times the MRHD based on AUC comparison). In an embryofetal developmental study in rabbits, sarecycline was administered to pregnant rabbits at oral doses up to 150 mg/kg/day during the period of organogenesis. Excessive maternal toxicity (mortality/moribundity/abortion) occurred at 150 mg/kg/day (5 times the MRHD based on AUC comparison) and this dose group was terminated early.

Maternal moribundity also occurred at 100 mg/kg/day (0.6 times the MRHD based on AUC comparison). No significant embryofetal toxicity or malformations were observed at doses up to 100 mg/kg/day (0.6 times the MRHD based on AUC comparison). In a pre- and post-natal developmental study in rats, sarecycline was administered to maternal rats at oral doses up to 400 mg/kg/day during the period of organogenesis through lactation.

Excessive litter toxicity (litter loss and stillbirth) occurred at 400 mg/kg/day (8 times the MRHD based on AUC comparison), which led to early termination of dams at parturition. Decreases in body weight and food consumption of dams during the lactation period occurred at 150 mg/kg/day (3 times the MRHD based on AUC comparison). Decreases in offspring survival and offspring body weight during the preweaning and growth period, and decreases in implantation sites and viable embryos in female offspring occurred at 150 mg/kg/day (3 times the MRHD based on AUC comparison).

No significant maternal or developmental toxicity was observed at 50 mg/kg/day (1.4 times the MRHD based on AUC comparison).

🧒 Pediatric Use 91 words ▾

8.4Pediatric Use The safety and effectiveness of SEYSARA have been established in pediatric patients 9 years of age and older for the treatment of moderate to severe inflammatory lesions of non-nodular acne vulgaris [see Pharmacokinetics ( 12.3 ) and Clinical Studies ( 14 )] . Safety and effectiveness of SEYSARA in pediatric patients below the age of 9 years has not been established. Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration [see Warnings and Precautions ( 5.1 )] .

🧓 Geriatric Use 27 words ▾

8.5Geriatric Use Clinical studies of SEYSARA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🆘 Overdosage 32 words ▾

10 OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Sarecycline is an aminomethylcycline within the tetracycline class of drugs. [see CLINICAL PHARMACOLOGY ( 12.4 )] . The mechanism of action of SEYSARA in treating the inflammatory lesions of non-nodular acne vulgaris is not known.

12.2Pharmacodynamics The pharmacodynamics of SEYSARA for the treatment of acne vulgaris are unknown. Cardiac Electrophysiology At approximately 3 times the maximum recommended dose, SEYSARA did not prolong the QT interval to a clinically relevant extent.

12.3Pharmacokinetics Increasing the SEYSARA dose from 60 to 150 mg once daily in healthy subjects resulted in a slightly less than proportional increase in sarcyeline steady-state C max and AUC tau . A mean accumulation ratio of sarecycline ranges from 1.5 to 1.6 fold with repeated dosing. Steady-state of sarecycline was reached by Day 7.

Absorption The median time to peak plasma concentration (T max ) of sarecycline is 1.5 to 2.0 hours. Effect of Food Coadministration with a high-fat (approximately 50% of total caloric content of the meal), high-calorie (800 to 1000 Kcal) meal that included milk delayed T max by approximately 0.53 hour and decreased sarecycline C max by 31% and AUC by 27%. Distribution Protein binding of sarecycline is 62.5% to 74.7% in vitro.

The mean apparent volume of distribution of sarecycline at steady-state ranges from

91.4 L to

97.0L. Elimination The mean apparent oral clearance (CL/F) of sarecycline at steady state is approximately 3 L/h. The mean elimination half-life of sarecycline is 21 to 22 hours.

Metabolism Metabolism of sarecycline by enzymes in human liver microsomes is minimal (< 15%) in vitro. Minor metabolites resulting from non-enzymic epimerization, O-/N-demethylation, hydroxylation, and desaturation have been found. Excretion After a single 100 mg oral dose of radiolabeled sarecycline, 42.6% of the dose was recovered in feces (14.9% as unchanged) and 44.1% in urine (24.7% as unchanged).

Specific Populations No clinically significant differences in the pharmacokinetics of sarecycline were observed based on age (11 to 73 years), weight (42 to 133 kg), sex, renal impairment, or mild to moderate hepatic impairment (Child Pugh A to B). The effect of end-stage renal disease (ESRD) or severe hepatic impairment (Child-Pugh C) on sarecycline pharmacokinetics has not been assessed. Drug Interaction Studies Clinical Studies Coadministration of SEYSARA with a combination oral contraceptive, ethinyl estradiol (EE) 20 mcg plus norethindrone (NE) acetate 1 mg, increased EE C max by 14% and AUC tau by 11%, and increased NE C max by 18% and AUC tau by 23%.

Coadministration of a single dose of SEYSARA 150 mg resulted in a 26% increase in C max of digoxin, a P-gp substrate. In Vitro Studies Sarecycline is not a substrate for P-gp, BCRP, OATP1B1, or OATP1B3. Sarecycline is a P-gp inhibitor.

Sarecycline does not inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4/5 isozymes, and does not inhibit OATP1B1, OATP1B3, OCT2, OAT1, OAT3, or BCRP. Sarecycline does not induce CYP1A2, CYP2B6, or CYP3A4/5 isozymes.

12.4Microbiology Mechanism of Action In P. acnes , sarecycline binds to the 30S ribosomal subunit and interacts with 16S ribosomal RNA. Furthermore, it protrudes its C7 moiety into the mRNA binding channel to interact with mRNA. Sarecycline blocks P. acnes protein synthesis and inhibits bacterial growth however, the clinical significance is unknown.

Resistance P. acnes strains displayed a low propensity for the development of resistance to sarecycline, with spontaneous mutation frequencies being 10 -10 at 4 – 8 × MIC. Antimicrobial Activity Sarecycline is active in vitro against most isolates of Propionibacterium acnes .

🧬 Mechanism of Action 39 words ▾

12.1Mechanism of Action Sarecycline is an aminomethylcycline within the tetracycline class of drugs. [see CLINICAL PHARMACOLOGY ( 12.4 )] . The mechanism of action of SEYSARA in treating the inflammatory lesions of non-nodular acne vulgaris is not known.

📦 How Supplied / Storage and Handling 133 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied 1) SEYSARA (sarecycline) tablets, 60 mg are capsule-shaped, yellow, film-coated tablets debossed with “S60” on one side and blank on the other side. Bottles of 30 tablets with child-resistant closure: NDC: 16110-245-30 2) SEYSARA (sarecycline) tablets, 100 mg are capsule-shaped, yellow, film-coated tablets debossed with “S100” on one side and blank on the other side. Bottles of 30 tablets with child-resistant closure: NDC: 16110-246-30 3) SEYSARA (sarecycline) tablets, 150 mg are capsule-shaped, yellow, film-coated tablets debossed with “S150” on one side and blank on the other side.

Bottles of 30 tablets with child-resistant closure: NDC: 16110-247-30 Storage Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [See USP Controlled Room Temperature]. Handling Protect from moisture and excessive heat.

📦 Storage and Handling 30 words ▾

Storage Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [See USP Controlled Room Temperature]. Handling Protect from moisture and excessive heat.

📋 Description 128 words ▾

11 DESCRIPTION SEYSARA (sarecycline) tablets are a tetracycline class drug for oral administration. Sarecycline hydrochloride is chemically described as (4 S ,4a S ,5a R ,12a S )-4-(dimethylamino)-3,10,12,12a-tetrahydroxy-7-[(methoxy-(methyl)-amino)- methyl]-1,11-dioxo-1,4,4a,5,5a,6,11, 12a-octahydrotetracene-2-carboxamide monohydrochloride with an empirical formula of C 24 H 29 N 3 O 8 .HCl and a molecular weight of 523.96. The structural formula is represented below: SEYSARA tablets contain 64.5 mg, 107.5 mg, and 161.2 mg of sarecycline hydrochloride equivalent to 60 mg, 100 mg, and 150 mg sarecycline respectively.

Inactive ingredients in the tablet formulations are: microcrystalline cellulose, povidone, sodium starch glycolate, and sodium stearyl fumarate. The yellow film coating contains D&C yellow #10 aluminum lake, iron oxide yellow, methacrylic acid copolymer type C, polyethylene glycol, polyvinyl alcohol, sodium bicarbonate, talc, and titatnium dioxide. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Patients taking SEYSARA should receive the following information and instructions: SEYSARA should not be used by pregnant women or women attempting to conceive a child [see Use in Specific Populations ( 8.1 )] . Advise a woman that breastfeeding is not recommended during SEYSARA therapy.

Advise patients that C. difficile colitis can occur with antibiotic therapy. If patients develop watery or bloody stools, they should seek medical attention. Advise patients that intracranial hypertension can occur with tetracycline therapy.

If patients experience headache or blurred vision, they should seek medical attention. Patients who experience central nervous system symptoms should be cautioned about driving vehicles or using hazardous machinery while on SEYSARA therapy. Patients should seek medical help for persistent central nervous system symptoms.

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Advise patients to minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using SEYSARA. If patients need to be outdoors while using SEYSARA, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician.

Treatment should be discontinued at the first evidence of skin erythema. Advise patients that because of the potential for drug-resistant bacteria to develop during the use of SEYSARA, take SEYSARA as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the current treatment course and increase the likelihood that bacteria will develop resistance and will not be treatable by other antibacterial drugs in the future.

Advise patients to drink fluids liberally along with SEYSARA to reduce the risk of esophageal irritation and ulceration [see Dosage and Administration ( 2 )] . © 2019 Almirall, LLC. All rights reserved. SEYSARA ® is a registered trademark of Almirall, LLC.

Almirall ® and its design are trademarks of Almirall, LLC. Distributed by: Almirall, LLC Malvern, PA 19355, USA Almirall

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Increasing the SEYSARA dose from 60 to 150 mg once daily in healthy subjects resulted in a slightly less than proportional increase in sarcyeline steady-state C max and AUC tau . A mean accumulation ratio of sarecycline ranges from 1.5 to 1.6 fold with repeated dosing. Steady-state of sarecycline was reached by Day 7.

Absorption The median time to peak plasma concentration (T max ) of sarecycline is 1.5 to 2.0 hours. Effect of Food Coadministration with a high-fat (approximately 50% of total caloric content of the meal), high-calorie (800 to 1000 Kcal) meal that included milk delayed T max by approximately 0.53 hour and decreased sarecycline C max by 31% and AUC by 27%. Distribution Protein binding of sarecycline is 62.5% to 74.7% in vitro.

The mean apparent volume of distribution of sarecycline at steady-state ranges from

91.4 L to

97.0L. Elimination The mean apparent oral clearance (CL/F) of sarecycline at steady state is approximately 3 L/h. The mean elimination half-life of sarecycline is 21 to 22 hours.

Metabolism Metabolism of sarecycline by enzymes in human liver microsomes is minimal (< 15%) in vitro. Minor metabolites resulting from non-enzymic epimerization, O-/N-demethylation, hydroxylation, and desaturation have been found. Excretion After a single 100 mg oral dose of radiolabeled sarecycline, 42.6% of the dose was recovered in feces (14.9% as unchanged) and 44.1% in urine (24.7% as unchanged).

Specific Populations No clinically significant differences in the pharmacokinetics of sarecycline were observed based on age (11 to 73 years), weight (42 to 133 kg), sex, renal impairment, or mild to moderate hepatic impairment (Child Pugh A to B). The effect of end-stage renal disease (ESRD) or severe hepatic impairment (Child-Pugh C) on sarecycline pharmacokinetics has not been assessed. Drug Interaction Studies Clinical Studies Coadministration of SEYSARA with a combination oral contraceptive, ethinyl estradiol (EE) 20 mcg plus norethindrone (NE) acetate 1 mg, increased EE C max by 14% and AUC tau by 11%, and increased NE C max by 18% and AUC tau by 23%.

Coadministration of a single dose of SEYSARA 150 mg resulted in a 26% increase in C max of digoxin, a P-gp substrate. In Vitro Studies Sarecycline is not a substrate for P-gp, BCRP, OATP1B1, or OATP1B3. Sarecycline is a P-gp inhibitor.

Sarecycline does not inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4/5 isozymes, and does not inhibit OATP1B1, OATP1B3, OCT2, OAT1, OAT3, or BCRP. Sarecycline does not induce CYP1A2, CYP2B6, or CYP3A4/5 isozymes.

12.4Microbiology Mechanism of Action In P. acnes , sarecycline binds to the 30S ribosomal subunit and interacts with 16S ribosomal RNA. Furthermore, it protrudes its C7 moiety into the mRNA binding channel to interact with mRNA. Sarecycline blocks P. acnes protein synthesis and inhibits bacterial growth however, the clinical significance is unknown.

Resistance P. acnes strains displayed a low propensity for the development of resistance to sarecycline, with spontaneous mutation frequencies being 10 -10 at 4 – 8 × MIC. Antimicrobial Activity Sarecycline is active in vitro against most isolates of Propionibacterium acnes .

🧬 Pharmacodynamics 36 words ▾

12.2Pharmacodynamics The pharmacodynamics of SEYSARA for the treatment of acne vulgaris are unknown. Cardiac Electrophysiology At approximately 3 times the maximum recommended dose, SEYSARA did not prolong the QT interval to a clinically relevant extent.

🔬 Clinical Studies 205 words ▾

14 CLINICAL STUDIES The safety and efficacy of once daily SEYSARA was assessed in two 12-week multicenter, randomized, double-blind, placebo-controlled studies (Study 1 [NCT02320149] and Study 2 [NCT02322866]). Efficacy was assessed in a total of 2002 subjects 9 years of age and older. Overall, 57% were female, 78% were Caucasian, 15% were Black or African American and 51% were adults (18 to 45 years of age).

Subjects were randomized to receive either SEYSARA or placebo once daily. The two co-primary efficacy endpoints were: Percentage of subjects with Investigator’s Global Assessment (IGA) success: a score of clear (0) or almost clear (1) and 2-point decrease from baseline on IGA score at Week 12. Absolute reduction from baseline in inflammatory lesion counts at Week 12.

The results at Week 12 are presented in the following table. Table 2: Clinical Efficacy of SEYSARA at Week 12 Study 1 Study 2 SEYSARA (N=483) Placebo (N=485) SEYSARA (N=519) Placebo (N=515) Investigator’s Global Assessment IGA Success 21.9% 10.5% 22.6% 15.3% Inflammatory Lesions Mean absolute reduction 15.3 10.2 15.5

11.1Mean percent reduction 52.2% 35.2% 50.8% 36.4% Mean absolute and percent reduction in inflammatory lesions was also greater with SEYSARA compared to placebo at Weeks 3, 6, and 9 for both studies.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year oral mouse carcinogenicity study and a 2-year oral rat carcinogenicity study, no drug-related neoplasms were observed in male mice at oral doses of sarecycline up to 100 mg/kg/day (approximately equal to the MRHD based on AUC comparison) or in female mice at doses up to 60 mg/kg/day (approximately equal to the MRHD based on AUC comparison), or in rats at doses up to 200/100 mg/kg/day (dose reduced from 200 to 100 mg/kg/day due to increased mortality; 8 times the MRHD based on AUC comparison).

Sarecycline was not mutagenic or clastogenic in a series of in vitro and in vivo genotoxicity studies, including a bacteria reverse mutation (Ames) assay, an in vitro chromosomal aberration assay in CHO cells, the L5178Y/TK +/- Mouse Lymphoma Assay, and an in vivo micronucleus assay in rats. In a fertility and early embryonic development study in rats, sarecycline was administered to both male and female rats at oral doses up to 400 mg/kg/day prior to pairing and through the mating and postmating period. Female fertility was not affected at doses up to 400 mg/kg/day (8 times the MRHD based on AUC comparison).

In sperm evaluation, decreased sperm motility, decreased sperm count and concentration, and an increase in percent abnormal sperm occurred at 400 mg/kg/day (8 times the MRHD based on AUC comparison). Male fertility was not affected at doses up to 150 mg/kg/day (4 times the MRHD based on AUC comparison).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year oral mouse carcinogenicity study and a 2-year oral rat carcinogenicity study, no drug-related neoplasms were observed in male mice at oral doses of sarecycline up to 100 mg/kg/day (approximately equal to the MRHD based on AUC comparison) or in female mice at doses up to 60 mg/kg/day (approximately equal to the MRHD based on AUC comparison), or in rats at doses up to 200/100 mg/kg/day (dose reduced from 200 to 100 mg/kg/day due to increased mortality; 8 times the MRHD based on AUC comparison).

Sarecycline was not mutagenic or clastogenic in a series of in vitro and in vivo genotoxicity studies, including a bacteria reverse mutation (Ames) assay, an in vitro chromosomal aberration assay in CHO cells, the L5178Y/TK +/- Mouse Lymphoma Assay, and an in vivo micronucleus assay in rats. In a fertility and early embryonic development study in rats, sarecycline was administered to both male and female rats at oral doses up to 400 mg/kg/day prior to pairing and through the mating and postmating period. Female fertility was not affected at doses up to 400 mg/kg/day (8 times the MRHD based on AUC comparison).

In sperm evaluation, decreased sperm motility, decreased sperm count and concentration, and an increase in percent abnormal sperm occurred at 400 mg/kg/day (8 times the MRHD based on AUC comparison). Male fertility was not affected at doses up to 150 mg/kg/day (4 times the MRHD based on AUC comparison).

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 07/2019 PATIENT INFORMATION SEYSARA® (SAY' sara) (sarecycline) tablets What is SEYSARA?

SEYSARA is a prescription medicine used to treat moderate to severe acne vulgaris in people 9 years and older. SEYSARA should not be used for the treatment or prevention of infections It is not known if SEYSARA is safe and effective for use for longer than 12 weeks. It is not known if SEYSARA is safe and effective in children under 9 years of age.

Do not take SEYSARA: if you are allergic to medicines in the tetracycline-class. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. What should I tell my healthcare provider before taking SEYSARA?

Before taking SEYSARA, tell your healthcare provider about all of your medical conditions, including if you: have diarrhea or watery stools have vision problems are pregnant or plan to become pregnant. SEYSARA may harm your unborn baby. Taking SEYSARA during the second and third trimesters of pregnancy may cause serious side effects on the growth of bone and teeth of your baby.

Stop taking SEYSARA and call your healthcare provider right away if you become pregnant during your treatment with SEYSARA. are breastfeeding or plan to breastfeed. SEYSARA can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take SEYSARA.

You should not breastfeed during treatment with SEYSARA. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SEYSARA and other medicines can affect each other causing serious side effects.

Especially tell your healthcare provider if you take: a blood thinner a penicillin antibiotic medicine antacids that contain aluminum, calcium or magnesium or iron-containing products an acne medication taken by mouth that contains isotretinoin or acitretin How should I take SEYSARA? Take SEYSARA exactly as your healthcare provider tells you. Skipping doses or not taking all doses of SEYSARA may: make the treatment not work as well. increase the chance that the bacteria will become resistant to SEYSARA.

Take SEYSARA 1 time a day with or without food. Take SEYSARA with enough fluid to completely swallow the tablet and to lower your risk of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.

If you take too much SEYSARA, stop taking SEYSARA and call your healthcare provider right away or go to the nearest hospital emergency room. What should I avoid during treatment with SEYSARA? Avoid sunlight or artificial sunlight, such as a tanning booth or sunlamp.

You could get severe sunburn. Use sunscreen and wear loose-fitting clothes that cover your skin while out in sunlight. Stop taking SEYSARA if you get sunburn.

You should not drive or operate dangerous machinery until you know how SEYSARA affects you. Tetracyclines may cause you to feel dizzy or lightheaded, or have a spinning feeling (vertigo). What are the possible side effects of SEYSARA?

SEYSARA may cause serious side effects, including: Harm to an unborn baby. See “ What should I tell my healthcare provider before taking SEYSARA? ” Permanent teeth discoloration. SEYSARA may permanently turn a baby or child's teeth yellow-gray-brown during tooth development.

You should not use SEYSARA during tooth development. Tooth development happens in the second and third trimesters of pregnancy, and from birth to 8 years of age. Slow bone growth.

SEYSARA may slow bone growth in infants and children. Slow bone growth is reversible after stopping treatment with SEYSARA. Diarrhea.

Diarrhea can happen with most antibiotics, including SEYSARA. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your healthcare provider right away if you get watery or bloody stool… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 51 words ▾

PRINCIPAL DISPLAY PANEL - NDC: 16110-245-30 - 60 mg 30-count Bottle Label 60 mg 30-count Bottle Label

PRINCIPAL DISPLAY PANEL - NDC: 16110-246-30 - 100 mg 30-count Bottle Label 100 mg 30-count Bottle Label

PRINCIPAL DISPLAY PANEL - NDC: 16110-247-30 - 150 mg 30-count Bottle Label 150 mg 30-count Bottle Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Seysara — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Seysara. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$223.1K
Claims incl. refills
173
Beneficiaries
102
Spend / beneficiary
$2,186.80
Spend / claim
$1,289.33
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Seysara (this brand).

Top reported reactions

Headache21
Dizziness13
Vision Blurred11
Rash9
Pruritus8
Fatigue7
Nausea7

Age at onset

Adolescent6
Adult16
Elderly1

Reporter sex

191 reports
Male · 28%
Female · 70%
Unknown · 2%

Serious outcomes

Hospitalization15
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 35 12
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Almirall, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 29000 tablets (16110-0246-00). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Almirall, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 16110-0245-30 · Almirall, 16110-0247-30 · Almirall, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.