HomeNDC LookupIngredientsTavaborole › 62332-0467-10
Tavaborole 43.5 mg/mL Solution — NDC 62332-0467-10 package photo

Tavaborole 43.5 mg/mL Solution

by Alembic Pharmaceuticals Inc. · 1 BOTTLE, DROPPER in 1 CARTON (62332-467-10) / 10 mL in 1 BOTTLE, DROPPER
NDC 62332-0467-10
🏷️ FDA NDC (as labeled) 62332-467-10 billing pads the product segment with a zero
This package
Contains10 mL in 1 bottle, dropper Cost per mL$3.49 NADAC Per package$34.90 / 10 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $29.68/unit · Part D plans $8.79/unit — full pricing hub ↓
Also comes in: 4 mL 62332-0467-04
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Tavaborole (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 6, 2025 — Discoloration (VIONA PHARMACEUTICALS INC) · FDA recall D-0016-2026
Class II · Aug 12, 2025 — Discoloration (VIONA PHARMACEUTICALS INC) · FDA recall D-0595-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 62332-467-10
Product NDC 62332-467
11-digit billing NDC 62332046710
NCPDP billing unit ML — per mL (volume)
RxCUI 1543177
UNII K124A4EUQ3
Application # ANDA212188
SPL Set ID 22a6617b-d4b1-405e-901a-0b39a7b2837d
Established class (EPC) Oxaborole Antifungal
Mechanism of action Protein Synthesis Inhibitors
Chemical class Boron Compounds
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-10-23
Route TOPICAL
Dosage form SOLUTION
Substance TAVABOROLE
GPI-14 90156080002010
GPI class Tavaborole
GCN Seq No 072716
GCN 36997
HICL code 041353
Ingredient (HICL) Tavaborole
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5F
Therapeutic class — specific (HIC3) Topical Antifungals
AHFS code 84:04.08.24
AHFS class Oxaboroles
FDB label name TAVABOROLE 5% TOPICAL SOLUTION
FDB brand name Tavaborole
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 62332-467-10 — 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 → 62332-0467-10. 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 Oxaborole Antifungal class.

Pharmacologic class Oxaborole Antifungal
Drug family (ATC) Other antifungals for topical use
How it works Protein Synthesis 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.

🏭 Manufacturer & labeler

LabelerAlembic Pharmaceuticals Inc.
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA212188 (ANDA)
Labeler code62332
First marketedOct 2020
Product typeHuman Prescription Drug
Portfolio491 products on file
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.

🩺 Clinical

Label name TAVABOROLE 5% TOPICAL SOLUTION Ingredient Tavaborole
📖 What it is MedlinePlus · NLM

Tavaborole topical solution is used to treat fungal toenail infections (infections that may cause nail discoloration, splitting, or pain). Tavaborole topical solution is in a class of medications called antifungals. It works by stopping the growth of nail fungus.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Tavaborole topical solution is used to treat a fungal infection of the toenails called onychomycosis. It works against the two fungi most commonly responsible — Trichophyton rubrum...
  • Yes, 48 weeks — about 11 months — is a long treatment course, and I understand that can feel like a lot. But here's the thing: toenails grow very slowly, and the fungus lives deep...
  • How long do I really need to use this for? That seems like a long time.
  • The most common side effects are local — some skin peeling, redness, or mild irritation right where you apply it, and occasionally an ingrown toenail. These are usually manageable....
📖 Read our full Tavaborole Topical guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Tavaborole — tap one for details:

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.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 25IH6R4SGF
    Edetate calcium disodium is a chelating agent, a chemical that binds to metal ions. It's used in some medications to prevent unwanted metals from interfering with the drug's stability and effectiveness.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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 mLPer package
Retail pharmacies payNADAC · weekly $3.490 $34.90 / 10 ml
Medicaid paysCMS SDUD · 12 mo $29.68 $296.78 / 10 ml
Medicare drug plans payPart D · Q2 2026 $8.79 $87.95 / 10 ml
NADAC price history (per mL) — tap or hover for the price & month
Aug 2021 Jan 2026 Apr 2026 Aug 2026 $12.679 $3.490
▼ Down 72% over the last 11 months.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tavaborole 43.5 mg/mL 21922-0020-12 Encube 1 bottle $3.490 AB Availability likely
Tavaborole 43.5 mg/mL 62135-0663-59 Chartwell 10 ml $3.490 AB Availability likely
Tavaborole 43.5 mg/mLthis 62332-0467-10 Alembic 1 bottle $3.490 AB Availability likely
Tavaborole 43.5 mg/mL 72578-0102-04 Viona 1 bottle $3.490 AB Availability likely
tavaborole 43.5 mg/mL 51862-0690-10 Mayne 1 bottle $5.041 AB Discontinued +44%
Tavaborole 43.5 mg/mL 46708-0467-04 Alembic 1 bottle AB FDA listed
Tavaborole 43.5 mg/mL 69097-0686-34 Cipla 1 bottle Discontinued
Tavaborole 43.5 mg/mL 69238-1657-04 Amneal 1 bottle Discontinued
Tavaborole 43.5 mg/mL 70771-1826-00 Zydus 1 bottle AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2020
On the market since
Oct 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 62332-0467-10, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1K
Units reimbursed last 4 qtrs
11.2K
Gross reimbursed last 4 qtrs
$332.9K
Avg / prescription
$327.97
Avg / unit
$29.6771
Latest quarter Q4 2025
518Rx
Medicaid pays / mL
$29.6771
gross reimbursed
vs
NADAC / mL
$3.4902
acquisition cost
=
Spread
+$26.1869
+750% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
100% FFS
Fee-for-service · 1,015 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 10,587 units · 54.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 630 units · 1.6 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.654.1
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 54.1 /100k
2 California 1.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle this page62332-0467-10 1,179 Rx · $60,224
1 bottle62332-0467-04 No Medicaid data
Drug total (last 4 qtrs): 1,179 Rx · 11,809 units · $60,224 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Tavaborole — the program that covers self-administered drugs. 4 manufacturers.
⚠️ 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 Tavaborole. 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
$7.61M
Claims incl. refills
11.6K
Beneficiaries
6.8K
Spend / beneficiary
$1,117.92
Spend / claim
$653.63
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 Tavaborole — the ingredient across all brands.

Top reported reactions

Injection Site Pain4
Product Dose Omission In Error4
Cough3
Product Packaging Quantity Issue3
Pruritus3
Rash3
Skin Irritation3

Age at onset

Adult7
Elderly18

Reporter sex

65 reports
Male · 17%
Female · 83%

Serious outcomes

Hospitalization3
Death2
Disabling1
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 13 2
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
62332-0467-04 1 BOTTLE, DROPPER in 1 CARTON (62332-467-04) / 4 mL in 1 BOTTLE, DROPPER 2020-10-23 Active
62332-0467-10 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (62332-467-10) / 10 mL in 1 BOTTLE, DROPPER $3.49 / mL $34.90 2020-10-23 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 62332-0467-10?
NDC 62332-0467-10 is listed by the FDA — 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Tavaborole 43.5 mg/mL Solution?
Bill NDC 62332-0467-10 — the 11-digit billing format is 62332046710. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 54 words

1 INDICATIONS AND USAGE Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes . Tavaborole topical solution is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes .

⏱️ Dosage and Administration 107 words

2 DOSAGE AND ADMINISTRATION Apply tavaborole topical solution to affected toenails once daily for 48 weeks. Tavaborole topical solution should be applied to the entire toenail surface and under the tip of each toenail being treated. Tavaborole topical solution is for topical use only and not for oral, ophthalmic, or intravaginal use.

Apply tavaborole topical solution to affected toenails once daily for 48 weeks. ( 2 ) Tavaborole topical solution should be applied to the entire toenail surface and under the tip of each toenail being treated. ( 2 ) For topical use only.

( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )

💊 Dosage Forms and Strengths 28 words

3 DOSAGE FORMS AND STRENGTHS Tavaborole topical solution, 5% is a clear, colorless alcohol-based solution. Each milliliter of solution contains 43.5 mg (5% w/w) of tavaborole. Solution, 5%.

Contraindications 4 words

4 CONTRAINDICATIONS None. None.

🤒 Adverse Reactions ~1 min read

6 ADVERSE REACTIONS Common adverse reactions occurring in ≥1% in subjects treated with tavaborole topical solution included application site exfoliation, ingrown toenail, application site erythema, and application site dermatitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc. at 1-866-210-9797 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. In two clinical trials, 791 subjects were treated with tavaborole topical solution. The most commonly reported adverse reactions are listed below (Table 1).

Table 1: Adverse Reactions Occurring in ≥1% of Tavaborole Topical Solution, 5%-Treated Subjects and at a Greater Frequency than Observed with Vehicle Preferred Term Tavaborole Topical Solution N=791 n(%) Vehicle N=395 n(%) Application site exfoliation 21 (2.7%) 1 (0.3%) Ingrown toenail 20 (2.5%) 1 (0.3%) Application site erythema 13 (1.6%) 0 (0%) Application site dermatitis 10 (1.3%) 0 (0%)

6.2Postmarketing Experience The following adverse reactions have been identified during postmarketing use of tavaborole topical solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug product exposure: Hypersensitivity; contact allergy

👥 Use in Specific Populations ~3 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on tavaborole topical solution use in pregnant women to inform a drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. In oral animal reproductive studies, administration of tavaborole during the period of organogenesis resulted in embryofetal toxicity and malformations at 570 times the Maximum Recommended Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons in rats and embryofetal toxicity at 155 times the MRHD based on AUC comparisons in rabbits.

Embryofetal toxicity was noted following dermal administration in rabbits up to 36 times the MRHD based on AUC comparisons [ see Data ]. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies carry some risk of birth defect, loss, or other adverse outcomes.

The background risk of major birth defects in the U.S. general population is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data Oral administration: In an oral embryofetal development study in rats, oral doses of 30, 100, and 300 mg/kg/day tavaborole were administered during the period of organogenesis (gestational days 6 to 19) to pregnant female rats. In the presence of maternal toxicity, embryofetal toxicity (increased embryofetal resorption and/or deaths) and drug-related skeletal malformations and variations suggestive of delayed development (i.e., a delay in ossification) were noted in fetuses at 300 mg/kg/day tavaborole [570 times the MRHD based on AUC comparisons].

No developmental toxicity was noted in rats at 100 mg/kg/day tavaborole (26 times the MRHD based on AUC comparisons). In an oral embryofetal development study in rabbits, oral doses of 15, 50, and 150 mg/kg/day tavaborole were administered during the period of organogenesis (gestational days 7 to 19) to pregnant female rabbits. In the presence of maternal toxicity, excessive embryofetal mortality due to post-implantation loss was noted at 150 mg/kg/day tavaborole.

No drug related malformations were noted in rabbits at 150 mg/kg/day tavaborole (155 times the MRHD based on AUC comparisons). No embryofetal mortality was noted in rabbits at 50 mg/kg/day tavaborole (16 times the MRHD based on AUC comparisons). In an oral prenatal and postnatal development study in rats, oral doses of 15, 60, and 100 mg/kg/day tavaborole were administered from the beginning of organogenesis (gestation day 6) through the end of lactation (lactation day 20).

In the presence of minimal maternal toxicity, no embryofetal toxicity or effects on postnatal development were noted at 100 mg/kg/day (29 times the MRHD based on AUC comparisons). Topical administration: In a dermal embryofetal development study in rabbits, topical doses of 1%, 5%, and 10% tavaborole solution were administered during the period of organogenesis (gestational days 6 to 28) to pregnant female rabbits. A dose dependent increase in dermal irritation at the treatment site was noted at 5% and 10% tavaborole solution.

A decrease in fetal bodyweight was noted at 10% tavaborole solution. No drug related malformations were noted in rabbits at 10% tavaborole solution (36 times the MRHD based on AUC comparisons). No embryofetal toxicity was noted in rabbits at 5% tavaborole solution (26 times the MRHD based on AUC comparisons).

8.2Lactation Risk Summary There is no information available on the presence of tavaborole topical solution in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production after topical application of tavaborole topical solution to women who are breastfeeding. Tavaborole topical solution is systemically absorbed. The lack of clinical data during lactation precludes a clear determination of the risk of tavaborole topical solution to a breastfed infant.

Therefore, the developmental and health benefits of breastfeeding…

🤰 Pregnancy ~2 min read

8.1Pregnancy Risk Summary There are no available data on tavaborole topical solution use in pregnant women to inform a drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. In oral animal reproductive studies, administration of tavaborole during the period of organogenesis resulted in embryofetal toxicity and malformations at 570 times the Maximum Recommended Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons in rats and embryofetal toxicity at 155 times the MRHD based on AUC comparisons in rabbits.

Embryofetal toxicity was noted following dermal administration in rabbits up to 36 times the MRHD based on AUC comparisons [ see Data ]. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies carry some risk of birth defect, loss, or other adverse outcomes.

The background risk of major birth defects in the U.S. general population is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data Oral administration: In an oral embryofetal development study in rats, oral doses of 30, 100, and 300 mg/kg/day tavaborole were administered during the period of organogenesis (gestational days 6 to 19) to pregnant female rats. In the presence of maternal toxicity, embryofetal toxicity (increased embryofetal resorption and/or deaths) and drug-related skeletal malformations and variations suggestive of delayed development (i.e., a delay in ossification) were noted in fetuses at 300 mg/kg/day tavaborole [570 times the MRHD based on AUC comparisons].

No developmental toxicity was noted in rats at 100 mg/kg/day tavaborole (26 times the MRHD based on AUC comparisons). In an oral embryofetal development study in rabbits, oral doses of 15, 50, and 150 mg/kg/day tavaborole were administered during the period of organogenesis (gestational days 7 to 19) to pregnant female rabbits. In the presence of maternal toxicity, excessive embryofetal mortality due to post-implantation loss was noted at 150 mg/kg/day tavaborole.

No drug related malformations were noted in rabbits at 150 mg/kg/day tavaborole (155 times the MRHD based on AUC comparisons). No embryofetal mortality was noted in rabbits at 50 mg/kg/day tavaborole (16 times the MRHD based on AUC comparisons). In an oral prenatal and postnatal development study in rats, oral doses of 15, 60, and 100 mg/kg/day tavaborole were administered from the beginning of organogenesis (gestation day 6) through the end of lactation (lactation day 20).

In the presence of minimal maternal toxicity, no embryofetal toxicity or effects on postnatal development were noted at 100 mg/kg/day (29 times the MRHD based on AUC comparisons). Topical administration: In a dermal embryofetal development study in rabbits, topical doses of 1%, 5%, and 10% tavaborole solution were administered during the period of organogenesis (gestational days 6 to 28) to pregnant female rabbits. A dose dependent increase in dermal irritation at the treatment site was noted at 5% and 10% tavaborole solution.

A decrease in fetal bodyweight was noted at 10% tavaborole solution. No drug related malformations were noted in rabbits at 10% tavaborole solution (36 times the MRHD based on AUC comparisons). No embryofetal toxicity was noted in rabbits at 5% tavaborole solution (26 times the MRHD based on AUC comparisons).

🧒 Pediatric Use 72 words

8.4Pediatric Use The safety and efficacy of tavaborole topical solution were established in patients 6 years of age and older. Use of tavaborole topical solution in these age groups is supported by evidence from adequate and well-controlled studies of tavaborole topical solution in adults with additional data from an open-label pharmacokinetics study of tavaborole in subjects 12 years to less than 17 years old [ see Clinical Pharmacology ( 12.3 )].

🧓 Geriatric Use 59 words

8.5Geriatric Use In clinical trials of 791 subjects who were exposed to tavaborole topical solution, 19% were 65 years of age and over, while 4% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

🧬 Clinical Pharmacology ~2 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tavaborole topical solution is an oxaborole antifungal [see Clinical Pharmacology ( 12.4 ) ].

12.2Pharmacodynamics At therapeutic doses, tavaborole topical solution is not expected to prolong QTc to any clinically relevant extent.

12.3Pharmacokinetics Tavaborole undergoes extensive metabolism. Renal excretion is the major route of elimination of the metabolites. In a clinical pharmacology trial of six healthy adult male volunteers who received a single topical application of 5% 14 C-tavaborole solution, tavaborole conjugates and metabolites were shown to be excreted primarily in the urine.

The pharmacokinetics (PK) of tavaborole was investigated in 24 adult subjects with distal subungual onychomycosis involving at least 4 toenails (including at least 1 great toenail) following a single dose and a 2-week daily topical application of 200 μL of a 5% solution of tavaborole to all ten toenails and 2 mm of skin surrounding each toenail. Steady state was achieved after 14 days of dosing. After a single dose, the mean (± standard deviation) peak concentration (C max ) of tavaborole was 3.5 ± 2.3 ng/mL (n=21 with measurable concentrations, range 0.618 to 10.2 ng/mL, LLOQ=0.5 ng/mL), and the mean AUC last ± SD was 44.4 ± 25.5 ng*hr/mL (n=21).

After 2 weeks of daily dosing, the mean C max ± SD was 5.2 ± 3.5 ng/mL (n=24, range 1.5 to 12.8 ng/mL), and the mean AUC τ ± SD was 75.8 ± 44.5 ng*hr/mL. In another study PK of tavaborole was investigated in 22 subjects aged 12 years to less than 17 years with distal subungual onychomycosis involving at least 4 toenails (including at least 1 great toenail with at least 20% involvement) following once daily application of 5% solution of tavaborole to all ten toenails and 2 mm of skin surrounding each toenail for 29 days.

On Day 29, the mean ± SD C max was 5.9 ± 4.9 ng/mL (n=21 with measurable concentrations, range 1.0 to 16.4 ng/mL, LLOQ=0.5 ng/mL), and the mean ± SD AUC 0-24 was 76.0 ± 62.5 ng*hr/mL. Drug Interaction Studies In Vitro Studies In vitro studies have shown that tavaborole, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.

12.4Microbiology Mechanism of Action The mechanism of action of tavaborole is inhibition of fungal protein synthesis. Tavaborole inhibits protein synthesis by inhibition of an aminoacyl-transfer ribonucleic acid (tRNA) synthetase (AARS). Activity in vitro and in clinical infections Tavaborole has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections [see Indications and Usage ( 1 ) ]: Trichophyton rubrum Trichophyton mentagrophytes Mechanism of Resistance Trichophyton mentagrophytes and Trichophyton rubrum strains from isolates collected in the clinical trials have not demonstrated resistance following repeated exposure to tavaborole.

🧬 Mechanism of Action 18 words

12.1Mechanism of Action Tavaborole topical solution is an oxaborole antifungal [see Clinical Pharmacology ( 12.4 ) ].

📦 How Supplied / Storage and Handling 213 words

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Tavaborole topical solution, 5% is a clear, colorless solution supplied in an amber glass bottle with a screw cap. At initial use, the screw cap is replaced with the dropper assembly. Tavaborole topical solution, 5% is supplied in the following presentations: NDC 62332-467-10: One bottle containing 10 mL of solution with one glass pointed-tip dropper.

NDC 62332-467-04: One bottle containing 4 mL of solution with one glass pointed-tip dropper.

16.2Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. CAUTION: Flammable. Keep away from heat and flame. Discard product within 3 months after insertion of the dropper. Keep bottle tightly closed. Keep out of reach of children. The Packaging of This Product Contains Dry Natural Rubber .

16.1How Supplied Tavaborole topical solution, 5% is a clear, colorless solution supplied in an amber glass bottle with a screw cap. At initial use, the screw cap is replaced with the dropper assembly. Tavaborole topical solution, 5% is supplied in the following presentations: NDC 62332-467-10: One bottle containing 10 mL of solution with one glass pointed-tip dropper.

NDC 62332-467-04: One bottle containing 4 mL of solution with one glass pointed-tip dropper.

📦 Storage and Handling 64 words

16.2Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. CAUTION: Flammable. Keep away from heat and flame. Discard product within 3 months after insertion of the dropper. Keep bottle tightly closed. Keep out of reach of children. The Packaging of This Product Contains Dry Natural Rubber .

📋 Description 99 words

11 DESCRIPTION Tavaborole topical solution, 5% contains tavaborole, 5% (w/w) in a clear, colorless alcohol-based solution for topical use. The active ingredient, tavaborole, is an oxaborole antifungal with the chemical name of 5-fluoro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole. The chemical formula is C 7 H 6 BFO 2 , the molecular weight is 151.93 and the structural formula is: Tavaborole is a white to off-white powder.

It is slightly soluble in water and freely soluble in ethanol and propylene glycol. Each mL of tavaborole topical solution contains 43.5 mg of tavaborole. Inactive ingredients include alcohol (73.11% v/v), edetate calcium disodium, and propylene glycol.

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💬 Information for Patients ~3 min read

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use) The patient should be told the following: The impact of nail polish or other cosmetic nail products on the efficacy of tavaborole topical solution has not been evaluated. Inform a health care professional if the area of application shows signs of persistent irritation (for example, redness, itching, swelling). Product is flammable.

Avoid use near heat or open flame. Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India.

Mfg. License No.: G/25/2216 PATIENT INFORMATION Tavaborole (ta'' va bor' ole) topical solution, 5% Important information: Tavaborole topical solution is for use on toenails only. Do not use tavaborole topical solution in your mouth, eyes, or vagina.

What is tavaborole topical solution? Tavaborole topical solution is a prescription medicine used to treat fungal infections of the toenails. It is not known if tavaborole topical solution is safe and effective in children less than 6 years age.

Before using tavaborole topical solution, tell your healthcare provider about all of your medical conditions, including if you: • are pregnant or plan to become pregnant. It is not known if tavaborole topical solution can harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if tavaborole topical solution passes into your breast milk.

Talk to your healthcare provider about the best way to feed your baby during your treatment with tavaborole topical solution. Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. How should I use tavaborole topical solution?

See the "Instructions for Use" at the end of this Patient Information for detailed information about the right way to use tavaborole topical solution. • Use tavaborole topical solution exactly as your healthcare provider tells you to use it. • Apply tavaborole topical solution to your affected toenails 1 time each day. • Tavaborole topical solution is used for 48 weeks. • It is not known if the use of nail polish or other cosmetic nail products (such as gel nails or acrylic nails) will affect how tavaborole topical solution works.

What should I avoid while using tavaborole topical solution? • Tavaborole topical solution is flammable. Avoid heat and flame while applying tavaborole topical solution to your toenail. What are the possible side effects of tavaborole topical solution?

The most common side effects of tavaborole topical solution include: skin peeling, ingrown toenail, redness, itching, and swelling. Tavaborole topical solution may cause irritation at or near the application site. Tell your healthcare provider if you develop irritation at the application site that does not go away.

These are not all of the possible side effects of tavaborole topical solution. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store tavaborole topical solution? • Store tavaborole topical solution at room temperature, between 68°F to 77°F (20°C to 25°C) • Tavaborole topical solution is flammable. Keep away from heat and flame. • Keep the bottle tightly closed. • Safely throw away tavaborole topical solution after 3 months of inserting the dropper. Keep tavaborole topical solution and all medicines out of the reach of children.

General information about the safe and effective use of tavaborole topical solution Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use tavaborole topical solution for a condition for which it was not prescribed. Do not give tavaborole topical solution to other people, even if they have the same symptoms that you have.

It may harm them. You can ask your pharmacist or hea…

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