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Ameluz FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 29, 2024.

FDA Approved: Yes (First approved May 10, 2016)
Brand name: Ameluz
Generic name: aminolevulinic acid
Dosage form: Gel
Previous Name: BF-200 ALA
Company: Biofrontera AG
Treatment for: Actinic Keratosis

Ameluz (aminolevulinic acid) is a porphyrin precursor used in combination with the BF-RhodoLED lamp for photodynamic therapy (PDT) treatment of actinic keratoses on the face and scalp.

Development timeline for Ameluz

DateArticle
Oct  7, 2024Approval FDA Approves Use of Up To Three Tubes of Biofrontera Inc.'s Ameluz (aminolevulinic acid HCI) Topical Gel, 10% In One Treatment
Oct 10, 2023Approval Biofrontera Inc. Receives FDA Approval for New Formulation of Ameluz
May 11, 2016Approval Biofrontera Announces U.S. FDA Approval of Ameluz and Activating BF-RhodoLED Device for Treatment of Actinic Keratosis
Sep 11, 2015FDA Accepts Filing of Ameluz and BFRhodoLED New Drug Application
Jul 13, 2015Biofrontera Submits New Drug Application for Ameluz to FDA

See also

Ameluz (aminolevulinic acid) Consumer information

Further information

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