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Fennec Pharmaceuticals Inc.
Fennec Pharmaceuticals Announces FDA Filing Acceptance and Priority Review of New Drug Application for PEDMARK™
Published Apr 13 2020
3 min read

Fennec Pharmaceuticals Announces FDA Filing Acceptance and Priority Review of New Drug Application for PEDMARK™

~ Potential for PEDMARK to be the First Product for the Prevention of Cisplatin-Induced Hearing Loss in Children ~

~ FDA Grants Priority Review and Sets a Prescription Drug User Fee Act (PDUFA) Target Action Date of August 10, 2020 ~

Research Triangle Park, N.C., April 13, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (Nasdaq: FENC; TSX: FRX), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review for the company’s New Drug Application (NDA) for PEDMARK(a unique formulation of sodium thiosulfate). PEDMARK is an investigational drug for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to