FDA Extends Decision on Filsuvez Gel for Skin Wounds to February

FDA Extends Decision on Filsuvez Gel for Skin Wounds to February

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FDA Extends Decision on Filsuvez Gel for Skin Wounds to February

The U.S. Food and Drug Administration (FDA) has extended by three months its review of Amryt Pharma’s application seeking approval of Filsuvez (Oleogel-S10), a topical gel to treat skin wounds in people epidermolysis bullosa (EB). A regulatory decision is now expected on Feb. 28 — it previously was set for Nov. 30 — according to the Prescription Drug User Fee Act date. The extension gives the FDA time to review additional data submitted earlier by Amryt, the…

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