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AMELUZ aminolevulinic acid hydrochloride 100 mg/g Gel — NDC 70621-0101-30 package photo

AMELUZ aminolevulinic acid hydrochloride 100 mg/g Gel

by Biofrontera Inc. · 1 TUBE in 1 PACKAGE (70621-101-30) / 2 g in 1 TUBE (70621-101-03)
NDC 70621-0101-30
🏷️ FDA NDC (as labeled) 70621-101-30 billing pads the product segment with a zero
This package
Contains2 g in 1 tube Pack sizes3 compare ↓
Also comes in: 2 g 70621-0101-10 10 tubes 70621-0101-20
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 10, 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

🆔 Identity & classification

FDA NDC (as labeled) 70621-101-30
Product NDC 70621-101
11-digit billing NDC 70621010130
NCPDP billing unit GM — per gram (weight)
RxCUI 1806645, 1806650
UNII V35KBM8JGR
Application # NDA208081
SPL Set ID 650daa9f-aeec-49ce-95b9-5fa20b988afd
Established class (EPC) Optical Imaging Agent; Porphyrin Precursor
Mechanism of action Fluorescence Contrast Activity
Chemical class Porphyrinogens
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-08-26
Route TOPICAL
Dosage form GEL
Substance AMINOLEVULINIC ACID HYDROCHLORIDE
GCN Seq No 072080
GCN 36177
HICL code 021920
Ingredient (HICL) Aminolevulinic Acid Hcl
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5J
Therapeutic class — specific (HIC3) Photoact,Topical Antineoplast,Premalignant Lesions
AHFS code 84:18.00.00
AHFS class Antiproliferants
FDB label name AMELUZ 10% GEL
FDB brand name Ameluz
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 70621-101-30 — 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 → 70621-0101-30. 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 Porphyrin Precursor class.

Pharmacologic class Porphyrin Precursor, Optical Imaging Agent
Drug family (ATC) Sensitizers used in photodynamic/radiation therapy
How it works Fluorescence Contrast Activity
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

LabelerBiofrontera Inc.
Application holderBIOFRONTERA INC
FDA applicationNDA208081 (NDA)
Labeler code70621
First marketedAug 2016
Product typeHuman Prescription Drug
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 AMELUZ 10% GEL Ingredient Aminolevulinic Acid Hcl
📗 Our plain-language guide HelloPharmacist
  • Ameluz is a gel your dermatologist or healthcare provider applies directly to your actinic keratosis lesions in the office — you don't take anything home. After the gel sits on you...
  • What exactly is this treatment, and do I do anything at home?
  • Honestly, many people do feel a burning or stinging sensation during the red-light step — that's very common and expected. The good news is it usually settles down within a few day...
  • Will it hurt? What should I expect during and after the treatment?
📖 Read our full Aminolevulinic Acid Topical guide →
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 ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 94255I6E2T
    Sodium phosphate dibasic dihydrate is a salt that helps control the acidity level of a medicine. It acts as a buffer and pH regulator to keep the medication stable and effective.
  • UNII 5QWK665956
    A salt derived from phosphoric acid and sodium, used primarily as a buffer to control the acidity or pH of a medication, helping keep it stable during storage and use.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

9 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 DailyMed — ingredient 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 gPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 2 g 10 tubes
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
Ameluz 100 mg/gthis 70621-0101-30 Biofrontera 1 tube — — 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

🏛️
2016
First FDA approval
May 2016
📍
2026
Currently FDA-listed
10 years listed
🛡️
2043
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 Dec 2043. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 10, 2016 RLD RS ⏳ ~17.2 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 11235169 — method of use (U-3303)
US 11540981 — drug product
US 12280146 — drug product
Exclusivity D-194
2016 2018 2020 2022 2024 2026 2028 2030 2032 2034 2036 2038 2040 2042 2044
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 (3)
PatentTypeUse codeExpires
US 11235169 ↗ Method of use U-3303 Oct 15, 2040
US 11540981 ↗ Drug product — Feb 7, 2028
US 12280146 ↗ Drug product — Dec 8, 2043
FDA exclusivity
CodeWhat it grantsExpires
D-194Other change requiring clinical data (3-year)Oct 4, 2027
Common questions
Is there a generic version of AMELUZ 10% GEL?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for AMELUZ 10% GEL. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Dec 2043 — 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.

💊 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.
10 tubes70621-0101-20 497 Rx · $49,356
1 tube70621-0101-10 32 Rx · $8,825
1 tube this page70621-0101-30 No Medicaid data
Drug total (last 4 qtrs): 529 Rx · 1,148 units · $58,181 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70621-0101-10 1 TUBE in 1 PACKAGE (70621-101-10) / 2 g in 1 TUBE (70621-101-01) 2017-06-01 Active
70621-0101-20 10 TUBE in 1 PACKAGE (70621-101-20) / 2 g in 1 TUBE (70621-101-01) 2021-05-10 Active
70621-0101-30 You're viewing this 1 TUBE in 1 PACKAGE (70621-101-30) / 2 g in 1 TUBE (70621-101-03) 2017-06-01 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 70621-0101-30?
NDC 70621-0101-30 is listed by the FDA — 1 tube in 1 package / 2 g in 1 tube.
What NDC number is used to bill for this package of AMELUZ aminolevulinic acid hydrochloride 100 mg/g Gel?
Bill NDC 70621-0101-30 — the 11-digit billing format is 70621010130. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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) ✓ 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 FDA registers it as 70621-101-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70621-0101-30, written without dashes as 70621010130. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70621-0101-30, the first segment (70621) is the labeler code FDA assigned to Biofrontera Inc.; the middle segment (0101) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Biofrontera Inc.. 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 2 other package presentations of this same product, including 1 tube (70621-0101-10), 10 tubes (70621-0101-20). 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?
Biofrontera Inc. 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.

📄 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 ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 82 words ▾

1. INDICATIONS AND USAGE AMELUZ, in combination with photodynamic therapy (PDT) using BF-RhodoLED ® or RhodoLED ® XL lamp, a narrowband, red light illumination source, is indicated for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp. AMELUZ, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED or RhodoLED XL lamp, is indicated for the lesion-directed and field-directed treatment of actinic keratoses (AK) of mild-to-moderate severity on the face and scalp ( 1 ).

⏱️ Dosage and Administration ~3 min read ▾

2. DOSAGE AND ADMINISTRATION Administer AMELUZ only by a health care provider ( 2.1 ). AMELUZ is for topical use only ( 2.1 ).

Use AMELUZ in combination with red light photodynamic therapy (PDT). See BF-RhodoLED or RhodoLED XL user manual for detailed lamp safety and operating instructions ( 2.1 ). Photodynamic therapy with AMELUZ involves preparation of lesions, application of the product, occlusion and illumination with BF-RhodoLED or RhodoLED XL lamp ( 2.3 ).

Apply an approximately 1 mm thick layer of AMELUZ to skin lesion(s). Cover individual lesions or the entire AK-field with AMELUZ. Include approximately 5 mm of the surrounding skin.

Do not exceed an application area of 60 cm 2 . Do not use more than 6 grams of AMELUZ (3 tubes) at one time ( 2.2 ). Retreat lesions that have not completely resolved 3 months after the initial treatment ( 2.2 ).

2.1Important Administration Information AMELUZ, in conjunction with lesion preparation, is only to be administered by a health care provider. AMELUZ is for topical use only. Not for ophthalmic, oral, or intravaginal use.

Treat single lesions or an entire field affected by multiple lesions with AMELUZ, in combination with red light photodynamic therapy (PDT). PDT requires administration of both AMELUZ and BF-RhodoLED or RhodoLED XL light. Refer to BF-RhodoLED or RhodoLED XL user manual for detailed lamp safety and operating instructions.

Adhere to all safety instructions for both patient and medical personnel while conducting the PDT.

2.2Recommended Dosage Apply an approximately 1-mm thick layer of AMELUZ to skin lesion(s). Cover individual lesions or the entire AK-field with AMELUZ. Include approximately 5 mm of the surrounding skin. Do not exceed an application area of 60 cm 2 . Do not use more than 6 grams of AMELUZ (3 tubes) at one time. Retreat lesions that have not completely resolved after 3 months after the initial treatment.

2.3Administration Instructions PDT is a multi-stage process: Step 1. Preparation of Lesions Before applying AMELUZ, carefully wipe all lesions with an ethanol or isopropanol-soaked cotton pad to ensure degreasing of the skin. Figure 1A: Degreasing the skin Thereafter, remove any scaling and crusts and gently roughen all lesion surfaces, taking care to avoid bleeding.

Figure 1B: Removal of scales and crusts Step 2. Application of AMELUZ Apply AMELUZ using glove protected fingertips or a spatula. Use sufficient amount of gel to cover individual lesions or the entire field: Lesion-directed treatment: Apply gel approximately 1 mm thick to one or more individual AK lesions and include approximately 5 mm of the surrounding healthy skin.

Field-directed treatment: Apply gel approximately 1 mm thick to the treatment field. Apply gel to the lesions and the skin in-between the lesions. Additionally, cover approximately 5 mm of the surrounding healthy area.

Do not exceed an application area of 60 cm 2 and do not use more than 6 grams of AMELUZ (3 tubes) at one time. The gel can be applied to healthy skin around the lesions. Avoid application near mucous membranes such as the eyes, nostrils, mouth, and ears (keep a distance of 1 cm from these areas).

In case of accidental contact with mucous membranes, thoroughly rinse with water [ see Warnings and Precautions (5.7) ]. Allow the gel to dry for approximately 10 minutes before applying occlusive dressing. Figure 2: Drug application Step 3.

Occlusion for 3 Hours Cover the area where the gel has been applied with a light-blocking, occlusive dressing. Following 3 hours of occlusion, remove the dressing and wipe off any remaining gel. Figure 3: Occlusion Step 4.

Illumination with Red Light For patient and medical personnel, wear suitable protective eyewear during illumination. Avoid staring directly into the light source [ see Warnings and Precautions (5.3) ]. Illuminate the treatment area with the BF-RhodoLED or RhodoLED XL lamp immediately after removing occlusion and any remaining gel.

BF-RhodoLED and RhodoLED XL la…

💊 Dosage Forms and Strengths 23 words ▾

3. DOSAGE FORMS AND STRENGTHS Topical gel: 10% aminolevulinic acid hydrochloride as a white-to-yellowish gel in 2-gram tubes. Gel: 10% ( 3 ).

⛔ Contraindications 92 words ▾

4. CONTRAINDICATIONS AMELUZ is contraindicated in patients with: Known hypersensitivity to porphyrins. Known hypersensitivity to any of the components of AMELUZ, which includes soybean phosphatidylcholine [see Warnings and Precautions (5.1) ] .

Porphyria. AMELUZ use may cause uncontrolled phototoxic effects [see Warnings and Precautions (5.5) ] . Photodermatoses.

PDT may worsen the phototoxic or photoallergic reactions [see Warnings and Precautions (5.5) ] . Known hypersensitivity to porphyrins ( 4 ). Known hypersensitivity to any component of AMELUZ, which includes soybean phosphatidylcholine ( 4 ).

Porphyria ( 4 ). Photodermatoses ( 4 ).

⚠️ Warnings and Cautions ~2 min read ▾

5. WARNINGS AND PRECAUTIONS Hypersensitivity: Hypersensitivity reactions have been reported with the use of AMELUZ prior to photodynamic therapy (PDT). If allergic reaction occurs, wash off AMELUZ and institute appropriate therapy ( 5.1 ).

Transient Amnestic Episodes: Transient amnestic episodes have been reported with use of AMELUZ in combination with PDT. Advise patients to contact their healthcare provider if amnesia or confusion occurs after treatment ( 5.2 ). Risk of BF-RhodoLED or RhodoLED XL Lamp Induced Eye Injury: Patients and healthcare providers must wear protective eyewear before operating BF-RhodoLED or RhodoLED XL lamp ( 5.3 ).

Ophthalmic Adverse Reactions: Avoid direct contact of AMELUZ with the eyes ( 5.4 ). Increased Photosensitivity: Protect treated lesions from sunlight exposure for 48 hours post treatment ( 5.5 ). Risk of Bleeding in Patients with Coagulation Disorders: Take special care to avoid bleeding during lesion preparation in patients with inherited or acquired coagulation disorders ( 5.6 ).

Mucous Membrane Irritation: Avoid direct contact of AMELUZ with the mucous membranes ( 5.7 ).

5.1Hypersensitivity Several cases of hypersensitivity were reported during postmarketing use of AMELUZ prior to PDT illumination [ see Adverse Reactions (6.2) ]. If allergic reactions occur, clean the area of skin where the product was applied and institute appropriate therapy. Inform patients and their caregivers that AMELUZ may cause hypersensitivity, potentially including severe courses (anaphylaxis).

5.2Transient Amnestic Episodes Transient amnestic episodes have been reported during postmarketing use of AMELUZ in combination with photodynamic therapy. Inform patients and their caregivers that AMELUZ in combination with photodynamic therapy may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment.

5.3Risk of BF-RhodoLED or RhodoLED XL Lamp Induced Eye Injury BF-RhodoLED or RhodoLED XL lamp may cause eye irritation, glare, or injury. Before operating the lamp, personnel must refer to the user manual for specific warnings, cautions, and instructions. Eye exposure to the BF-RhodoLED or RhodoLED XL light must be prevented.

Protective eye equipment must be used by patient, healthcare providers and any person present during the illumination period. Avoid staring directly into the light source.

5.4Ophthalmic Adverse Reactions Eyelid edema and dry eyes have occurred after PDT with AMELUZ. PDT with AMELUZ can cause ophthalmic adverse reactions. Avoid direct contact of AMELUZ with the eyes. Rinse eyes with water in case of accidental contact.

5.5Increased Photosensitivity AMELUZ increases photosensitivity. Avoid sunlight, prolonged or intense light (e.g., tanning beds, sun lamps) on lesions and surrounding skin treated with AMELUZ for approximately 48 hours following treatment, whether exposed to illumination or not. Concomitant use of AMELUZ with other known photosensitizing agents may increase the risk of phototoxic reaction to PDT [see Drug Interactions (7) ] .

5.6Risk of Bleeding in Patients with Coagulation Disorders AMELUZ has not been tested on patients with inherited or acquired coagulation disorders. Take special care to avoid bleeding during lesion preparation in such patients [ see Dosage and Administration (2.3) ] . Any bleeding must be stopped before application of the gel.

5.7Risk of Mucous Membrane Irritation AMELUZ can cause mucous membrane irritation. AMELUZ is intended for topical use only. Avoid direct contact of AMELUZ to the mucous membranes. Rinse with water in case of accidental contact.

🤒 Adverse Reactions ~3 min read ▾

6. ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: ​ Hypersensitivity [ see Warnings and Precautions (5.1) ]. Transient Amnestic Episodes [ see Warnings and Precautions (5.2) ] .

Risk of BF-RhodoLED or RhodoLED XL Lamp Induced Eye Injury [see Warnings and Precautions (5.3) ] . Ophthalmic Adverse Reactions [see Warnings and Precautions (5.4) ]. Increased Photosensitivity [see Warnings and Precautions (5.5) ] .

Most common adverse reactions (≥10%) were application site erythema, pain/burning, irritation, edema, pruritus, exfoliation, scab, induration, and vesicles ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Biofrontera Inc. at 1-844-829-7434 or FDA at 1-800-332-1088 or www.fda.gov/medwatch .

6.1Clinical Trial 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. The clinical program for AMELUZ included three double-blind and placebo-controlled phase 3 trials (Trials 1, 2, and 3), enrolling a total of 299 subjects that were treated with narrow band light. Trial subjects were adults greater than or equal to 49 years of age, and the majority had Fitzpatrick skin type I, II, or III.

No subjects had Fitzpatrick skin type V or VI. Approximately 86% of subjects were male, and all subjects were White. For all three phase 3 trials, the enrolled subjects had mild to moderate AKs (Olsen grade 1 and 2) with 4 to 8 lesions on the face and scalp.

Overall, 212 AMELUZ-treated subjects (n=32, n=55, and n=125) and 87 subjects receiving placebo (n=16, n=32, n=39) were illuminated with BF-RhodoLED or similar narrow spectrum lamps. For these trials, the maximal dose was one tube of AMELUZ (2 g) and the size of the application area was up to 20 cm 2 . Local skin reactions at the application site were observed in about 99.5% of subjects treated with AMELUZ and narrow spectrum lamps.

The most frequent adverse reactions during and after PDT were application site erythema, pain, burning, irritation, edema, pruritus, exfoliation, scab, induration, and vesicles. Most adverse reactions occurred during illumination or shortly afterwards, were generally of mild or moderate intensity, and lasted for 1 to 4 days in most cases; in some cases, however, they persisted for 1 to 2 weeks or even longer. Severe pain/burning occurred in up to 30% of subjects.

In one case, the adverse reactions required interruption or discontinuation of the illumination. Table 1 presents the incidence of common (≥1%, <10%) and very common (≥10%) adverse reactions at the application site in randomized, multicenter trials which evaluated a maximal dose of one tube of AMELUZ (2 g) and an application area up to 20 cm 2 . Table 1: Incidence of Adverse Reactions Occurring at ≥1% of the AMELUZ Group and More Frequently than the Vehicle Group in Actinic Keratosis Trials 1, 2, and 3 at the Application Site Adverse reaction Vehicle n=87 AMELUZ n=212 Adverse reactions at the application site Erythema Pain/Burning Irritation Edema Pruritus Exfoliation Scab Induration Vesicles Paresthesia Hyperalgesia Reaction Discomfort Erosion Discharge Bleeding Pustules 34 (39%) 26 (30%) 17 (20%) 3 (3%) 14 (16%) 4 (5%) 2 (2%) 0 (0%) 1 (1%) 2 (2%) 0 (0%) 2 (2%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 195 (92%) 195 (92%) 153 (72%) 75 (35%) 72 (34%) 41 (19%) 41 (19%) 26 (12%) 25 (12%) 18 (9%) 13 (6%) 8 (4%) 7 (3%) 6 (3%) 4 (2%) 3 (1%) 3 (1%) Common (≥1%, <10%) adverse reactions not at the application site for AMELUZ maximal dose of one tube (2 g) and application area up to 20 cm 2 were headache, skin exfoliation, chills and eyelid edema.

Less common (≥0.1%, <1%) adverse reactions at the application site for AMELUZ maximal dose of one tube (2 g) and application area up to 20 cm 2 were hemorrhage and swelling. The adverse re…

🔄 Drug Interactions 85 words ▾

7. DRUG INTERACTIONS There have been no formal studies of the interaction of AMELUZ with other drugs. It is possible that concomitant use of other known photosensitizing agents such as St.

John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines may enhance the phototoxic reaction to PDT [see Warnings and Precautions (5.3) ] . Concomitant use of the following medications may enhance the phototoxic reaction to photodynamic therapy: St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones, and tetracyclines ( 7 ).

👥 Use in Specific Populations ~1 min read ▾

8. USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on AMELUZ use in pregnant women to inform a drug associated risk. Animal reproduction studies were not conducted with aminolevulinic acid. Systemic absorption of aminolevulinic acid in humans is negligible following topical administration of AMELUZ under maximal clinical use conditions [see Clinical Pharmacology (12.3) ] .

It is not expected that maternal use of AMELUZ will result in fetal exposure to the drug. The background risk of major birth defects and miscarriage for the indicated population are 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.

8.2Lactation Risk Summary No data are available regarding the presence of aminolevulinic acid in human milk, the effects of aminolevulinic acid on the breastfed infant or on milk production. However, breastfeeding is not expected to result in exposure of the child to the drug due to the negligible systemic absorption of aminolevulinic acid in humans following topical administration of AMELUZ under maximal clinical use conditions [see Clinical Pharmacology (12.3) ] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AMELUZ and any potential adverse effects on the breastfeeding child from AMELUZ or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 have not been established. AK is not a condition generally seen in the pediatric population.

8.5Geriatric Use Of the 384 subjects exposed to AMELUZ in randomized, multicenter clinical trials, 83% (318/384) of the subjects were 65 years old 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.

🤰 Pregnancy 115 words ▾

8.1Pregnancy Risk Summary There are no available data on AMELUZ use in pregnant women to inform a drug associated risk. Animal reproduction studies were not conducted with aminolevulinic acid. Systemic absorption of aminolevulinic acid in humans is negligible following topical administration of AMELUZ under maximal clinical use conditions [see Clinical Pharmacology (12.3) ] .

It is not expected that maternal use of AMELUZ will result in fetal exposure to the drug. The background risk of major birth defects and miscarriage for the indicated population are 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.

🧒 Pediatric Use 29 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 have not been established. AK is not a condition generally seen in the pediatric population.

🧓 Geriatric Use 52 words ▾

8.5Geriatric Use Of the 384 subjects exposed to AMELUZ in randomized, multicenter clinical trials, 83% (318/384) of the subjects were 65 years old 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 Photoactivation following topical application of AMELUZ occurs when aminolevulinic acid (prodrug) is metabolized to protoporphyrin IX (PpIX), a photoactive compound which accumulates in the skin. When exposed to red light of a suitable wavelength and energy, PpIX is activated resulting in an excited state of porphyrin molecules. In the presence of oxygen, reactive oxygen species are formed which causes damage to cellular components, and eventually destroys the cells.

AMELUZ photodynamic therapy of AK lesions utilizes photoactivation of topically applied AMELUZ resulting from BF-RhodoLED or RhodoLED XL illumination, which provides a red light of narrow spectrum and a light dose of approximately 37 J/cm 2 .

12.2Pharmacodynamics The pharmacodynamics of AMELUZ in the treatment of actinic keratosis are unknown.

12.3Pharmacokinetics Aminolevulinic acid acts as a prodrug to the photoactive metabolite protoporphyrin IX (PpIX). Pharmacokinetics (PK) of aminolevulinic acid and PpIX were evaluated in two trials: In the first trial, a single dose of one entire tube of AMELUZ (2 grams) was applied under occlusion for 3 hours followed by PDT to a total area of 20 cm 2 in 12 adult subjects with mild to moderate AK with at least 10 AK lesions on the face or forehead. The mean ± SD baseline plasma aminolevulinic acid concentration was 20.16 ± 16.53 ng/mL.

In most subjects, an up to 2.5-fold increase of aminolevulinic acid plasma concentrations was observed during the first 3 hours after AMELUZ application. The mean ± SD area under the concentration time curve (AUC 0-t ) and maximum concentration (C max ) for baseline corrected aminolevulinic acid (n=12) were 142.83 ± 75.50 ng·h/mL and 27.19 ± 20.02 ng/mL, respectively. The median T max (time at which C max occurred) was 3 hours.

The mean ± SD baseline plasma PpIX concentration was 3.27 ± 2.40 ng/mL (n=12). The majority (about 55%) of the PpIX concentrations were below the limit of quantification (LOQ = 1 ng/mL) and baseline corrected values were negative in all subjects except for one. The baseline corrected AUC 0-t and C max in the single subject was 0.07 ng·h/mL and 0.29 ng/mL, respectively.

In the second trial, a single dose of three entire tubes of AMELUZ (6 grams) was applied under occlusion for 3 hours followed by PDT to a total area of 60 cm 2 in 16 adult subjects with mild to severe AK with at least 12 AK lesions on the face and scalp. The mean ± SD baseline plasma aminolevulinic acid concentration was 13.53 ± 1.58 ng/mL. In most subjects, an up to 2.5-fold increase of aminolevulinic acid plasma concentrations was observed during the first 3 hours after AMELUZ application.

The mean ± SD area under the concentration time curve (AUC 0-t ) and maximum concentration (C max ) for baseline corrected aminolevulinic acid (n=16) were 134.24 ± 87.97 ng·h/mL and 33.85 ± 21.85 ng/mL, respectively. The median T max (time at which C max occurred) was 3 hours. The mean ± SD baseline plasma PpIX concentration was 1.93 ± 0.42 ng/mL (n=15).

The mean ± SD baseline corrected C max of PpIX was 0.67 ± 0.78 ng/mL (n=13) with a median T max of 4 hours. The baseline corrected PpIX concentrations in 14 of 15 subjects were < 1 ng/mL.

🧬 Mechanism of Action 109 words ▾

12.1Mechanism of Action Photoactivation following topical application of AMELUZ occurs when aminolevulinic acid (prodrug) is metabolized to protoporphyrin IX (PpIX), a photoactive compound which accumulates in the skin. When exposed to red light of a suitable wavelength and energy, PpIX is activated resulting in an excited state of porphyrin molecules. In the presence of oxygen, reactive oxygen species are formed which causes damage to cellular components, and eventually destroys the cells.

AMELUZ photodynamic therapy of AK lesions utilizes photoactivation of topically applied AMELUZ resulting from BF-RhodoLED or RhodoLED XL illumination, which provides a red light of narrow spectrum and a light dose of approximately 37 J/cm 2 .

📦 How Supplied / Storage and Handling 109 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING AMELUZ (aminolevulinic acid hydrochloride) topical gel, 10% is a white-to-yellowish gel. The drug product is supplied in an aluminum tube with a white, high density polyethylene (HDPE) screw cap.

Each tube contains 2 g of gel. NDC 70621-101-01 2 g tube NDC 70621-101-10 Cardbox containing one 2 g tube NDC 70621-101-20 Cardbox containing ten 2 g tubes Store AMELUZ in a refrigerator, 2°C – 8°C (36°F – 46°F). Excursions permitted to 15°C – 30°C (59°F – 86°F).

After opening, AMELUZ can be stored for up to 12 weeks in a refrigerator at 2°C – 8°C (36°F – 46°F) if the tube is tightly closed.

📋 Description 124 words ▾

11. DESCRIPTION AMELUZ (aminolevulinic acid hydrochloride) topical gel, 10% is a non-sterile white-to-yellowish gel. The gel formulation contains a nanoemulsion.

Aminolevulinic acid, a porphyrin precursor, is a white to off-white crystalline solid. It is readily soluble in water, methanol, and dimethylformamide. Its chemical name is 5-amino-4-oxo-pentanoic acid hydrochloride, molecular weight is 167.59 and molecular formula is C 5 H 9 NO 3 ·HCl.

The structural formula of aminolevulinic acid hydrochloride is represented below: Each gram of AMELUZ contains 100 mg of aminolevulinic acid hydrochloride (equivalent to 78 mg aminolevulinic acid) as the active ingredient and the following inactive ingredients: xanthan gum, soybean phosphatidylcholine, polysorbate 80, medium-chain triglycerides, isopropyl alcohol, dibasic sodium phosphate, monobasic sodium phosphate, sodium benzoate and purified water. ALA.HCl - Structural Formula

💬 Information for Patients 183 words ▾

17. PATIENT COUNSELING INFORMATION Inform patients of the following: Hypersensitivity Hypersensitivity has been reported with use of AMELUZ. Inform patients and their caregivers that AMELUZ may cause hypersensitivity potentially including severe courses (anaphylaxis) [see Warnings and Precautions (5.1) ] .

Transient amnestic episodes Transient amnestic episodes have been reported with use of AMELUZ in combination with photodynamic therapy. Advise patients and their families or caregivers to contact their healthcare provider if memory impairment, confusion, or disorientation is observed [see Warnings and Precautions (5.2) ] . Photosensitivity Advise patients that for approximately 48 hours following treatment to avoid exposure to sunlight, and prolonged or intense light on the treated lesion sites and surrounding skin.

Advise patients to avoid certain medications that may enhance the phototoxic reaction to PDT [see Warnings and Precautions (5.5) and Drug Interactions (7) ]. Common adverse reactions Inform patients that treatment with AMELUZ in combination with PDT may result in adverse reactions which include local skin reactions at the application site such as erythema, pain/burning, irritation, edema, pruritus, exfoliation, induration, scab, and vesicles [ see Clinical Trial Experience (6.1) ].

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