FDA Accepts Biofrontera sNDA Filing for Ameluz PDT in Superficial Basal Cell Carcinoma

Reuters02-11 22:15

FDA Accepts Biofrontera sNDA Filing for Ameluz PDT in Superficial Basal Cell Carcinoma

Biofrontera Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of the company’s supplemental New Drug Application (sNDA) for Ameluz® (aminolevulinic acid hydrochloride) topical gel in combination with the RhodoLED® red-light lamp series for the treatment of superficial basal cell carcinoma (sBCC). The FDA identified no filing deficiencies and assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 28, 2026. If approved, Ameluz® would become the first and only photodynamic therapy $(PDT)$ photosensitizer indicated for the treatment of sBCC in the United States. The new indication would represent an expansion of Ameluz®'s clinical use beyond its current FDA approval for the treatment of actinic keratosis.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Biofrontera Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9652914-en) on February 11, 2026, and is solely responsible for the information contained therein.

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The FDA identified no filing deficiencies and assigned a Prescription Drug User Fee Act  target action date of September 28, 2026. If approved, Ameluz would become the first and only photodynamic therapy  photosensitizer indicated for the treatment of sBCC in the United States. The new indication would represent an expansion of Ameluz's clinical use beyond its current FDA approval for the treatment of actinic keratosis.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. 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The FDA identified no filing deficiencies and assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 28, 2026. If approved, Ameluz® would become the first and only photodynamic therapy $(PDT)$ photosensitizer indicated for the treatment of sBCC in the United States. The new indication would represent an expansion of Ameluz®'s clinical use beyond its current FDA approval for the treatment of actinic keratosis.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Biofrontera Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. 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