Ameluz (aminolevulinic acid hydrochloride) topical gel, 10% — photodynamic therapy
FDA PDUFA Target Action Date · Biofrontera Inc.
Note: Biofrontera Inc. first-quarter 2026 results press release, filed as SEC 8-K EX-99.1 on 2026-05-14: 'Announced FDA's completion of its filing review and filing acceptance of the Company's supplemental New Drug Application (sNDA) for Ameluz PDT for the treatment of superficial basal cell carcinoma (sBCC), with a PDUFA target action date of September 28, 2026.' Ameluz is Biofrontera's aminolevulinic acid HCl topical gel used in photodynamic therapy, already approved in the U.S. for actinic keratosis; this sNDA is a label expansion into sBCC. No FDA designations disclosed in the release, so none are asserted here. Biofrontera Inc. (Nasdaq: BFRI) is the U.S. licensee; the product originates with Biofrontera AG. No approval or CRL as of 2026-08-02 (Biofrontera's only 8-K since is a 2026-06-17 Item 5.07 annual-meeting filing). This entry is absent from both pdufa-manual.json and pdufa-calendar.json.
Drug Information
- Drug Name
- Ameluz (aminolevulinic acid hydrochloride) topical gel, 10% — photodynamic therapy (CT.gov)
- Application Type
- sNDA
- Indication
- Superficial basal cell carcinoma (sBCC)
Filing Details
- Company
- Biofrontera Inc. →
- Stock Ticker
- BFRI
- SEC CIK
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
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Data sourced from SEC EDGAR filings. Last updated: 2026-08-02. Report an issue