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# FDA Extends Oelogel-S10 Review Date
- URL: https://www.fdaweb.com/fda-extends-oelogel-s10-review-date/
- Published: 2021-11-23T12:00:00.000Z
- Updated: 2026-09-14T17:23:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150632

FDA has extended for three months to 2/28/2022 the PDUFA action date for Amryt’s NDA for Oleogel-S10 to treat cutaneous manifestations of junctional and dystrophic epidermolysis bullosa (EB). FDA said the extension was needed to give it time to review additional analyses of data previously submitted by the company. The agency determined that the data submission was a major amendment to the NDA.

FDA informed Amtyr 6/2021 that the NDA had been accepted and granted priority review.

The company [says](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=newssearch&cd=&cad=rja&uact=8&ved=2ahUKEwiBsPfb4q70AhVUMH0KHUOLAwE4FBDF9AEoAHoECA4QAg&url=https%3A%2F%2Fwww.globenewswire.com%2Fnews-release%2F2021%2F11%2F23%2F2339678%2F0%2Fen%2FAmryt-Provides-Update-on-Regulatory-Review-Process-for-Oleogel-S10.html&usg=AOvVaw2EiSJyHcdKYyFEvwaIuJ8l) EB is a “rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.”