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Oleogel-S10 FDA Approval Status

FDA Approved: No
Brand name: Oleogel-S10
Generic name: birch triterpenes
Company: Amryt
Treatment for: Epidermolysis Bullosa

Oleogel-S10 (birch triterpenes) is a herbal medicinal product in development for the treatment of the cutaneous manifestations of junctional and dystrophic epidermolysis bullosa.

Development timeline for Oleogel-S10

Feb 28, 2022Amryt Receives Complete Response Letter from the FDA for Oleogel-S10 NDA
Nov 23, 2021Amryt Provides Update on Regulatory Review Process for Oleogel-S10
Jun  3, 2021FDA Grants Priority Review for New Drug Application for Oleogel-S10 for the Treatment of Epidermolysis Bullosa

Further information

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