Fennec Pharmaceuticals Announces FDA Filing Acceptance and Priority Review of New Drug Application for PEDMARK™
Fennec Pharmaceuticals Inc. (FENC)
Last fennec pharmaceuticals inc. earnings: 11/12 06:00 am
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Source: GlobeNewswire
~ 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 "The FDA filing acceptance of our NDA and granting of Priority Review represents a significant milestone in the development of PEDMARK and we look forward to working closely with the Agency during this review process,” said Rosty Raykov, chief executive off
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