Fennec Pharmaceuticals : FDA Accepts Pedmark Application's Resubmission

 Fennec Pharmaceuticals Inc. on Wednesday said the U.S. Food and Drug Administration has accepted for filing its resubmitted application seeking approval of Pedmark for the prevention of hearing loss associated with cisplatin chemotherapy in children.

The Durham, N.C., specialty pharmaceutical company said the agency set a target action date of Sept. 23 for the application.

The FDA in November rejected Fennec's application for Pedmark, the company's lead drug candidate, for a second time due to issues at the plant where the drug is made.

https://www.marketscreener.com/quote/stock/FENNEC-PHARMACEUTICALS-IN-38066168/news/Fennec-Pharmaceuticals-FDA-Accepts-Pedmark-Application-s-Resubmission-40168368/