FDA OK's Berlex' Finevin acne cream

7 May 2001

The US affiliate of Schering AG, Berlex Laboratories, has receivedapproval from the US Food and Drug Administration for the marketing of Finevin (azelaic acid cream 20%), already available as Skinoren in Europe, for the treatment of mild-to-moderate inflammatory acne vulgaris.

Finevin will be the second dermatological product to be launched by Berlex as it builds a franchise in skin diseases in the USA, after Levulan PDT (aminolaevulinic acid) for actinic keratoses. After its introduction, scheduled for mid-May, Finevin will be the second azelaic acid-based product on the US market after Allergan's Azelex.

Clinical studies have shown that Finevin demonstrated antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermis, normalizes follicular hyperkeratosis associated with acne, has anti-inflammatory effects and leads to the reduction of acne lesions whilst displaying minimal side-effects.

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