BFRI
Ameluz (aminolevulinic acid hydrochloride) topical gel, 10% — photodynamic therapy
FDA PDUFA Target Action Date · Biofrontera Inc.
Monday, September 28, 2026
Approved
approved Note: Approved 2026-09-09 as AMELUZ (SUPPL NDA208081). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 19d from the PDUFA date.
Drug Information
- Drug Name
- Ameluz (aminolevulinic acid hydrochloride) topical gel, 10% — photodynamic therapy (CT.gov)
- Application Type
- sNDA
- Indication
- Superficial basal cell carcinoma (sBCC)
- Approved As
- Ameluz (aminolevulinic acid hydrochloride) topical gel, 10% — photodynamic therapy
Filing Details
- Company
- Biofrontera Inc. →
- Stock Ticker
- BFRI
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