FDA Approves Use of Up To Three Tubes of Biofrontera Inc.’s Ameluz (aminolevulinic acid HCI) Topical Gel, 10% In One Treatment
Biofrontera Inc. (BFRI)
Company Research
Source: GlobeNewswire
Approval allows for larger field treatment of actinic keratosis (AK) on face and scalp with Ameluz®-PDT using the BF-RhodoLED or the RhodoLED XL lampSupplemental New Drug Application (sNDA) supported by two Phase 1 safety studiesAK is the second most common diagnosis made by dermatologists in the United States1An estimated 13 million treatments given each year for AK in the US2 WOBURN, Mass., Oct. 07, 2024 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s sNDA to increase the maximally approved dosage from one to three tubes of Ameluz® per treatment. This approval allows healthcare professionals greater flexibility in addressing larger or multiple treatment areas for patients undergoing photodynamic therapy (PDT) for AK on the face and scalp, leading to greater con
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BFRI
Earnings
- 11/13/24 - Miss
BFRI
Sec Filings
- 11/14/24 - Form SC
- 11/14/24 - Form SC
- 11/14/24 - Form 10-Q
- BFRI's page on the SEC website