FRX Fennec Pharmaceuticals Inc

By Colin Kellaher

Fennec Pharmaceuticals Inc. on Thursday said it has once again resubmitted its new-drug application for Pedmark, its lead drug candidate, to the U.S. Food and Drug Administration.

The FDA in November rejected Fennec's application for a second time due to issues at the plant where the drug is made, sending shares of the Durham, N.C., specialty pharmaceutical company tumbling.

Fennec, which is seeking approval of Pedmark for the prevention of hearing loss associated with cisplatin chemotherapy in children, at the time said it would work closely with its current manufacturer and the FDA to address the issues raised in the letter, and that it was working to advance a second manufacturing plant.

"We appreciate the FDA's comments during the resubmission process and look forward to working closing with the Agency during the NDA review," Fennec said Thursday.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

March 24, 2022 06:29 ET (10:29 GMT)

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