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Pedmark FDA Approval Status

FDA Approved: No
Brand name: Pedmark
Generic name: sodium thiosulfate
Company: Fennec Pharmaceuticals Inc.
Treatment for: Prevention of Cisplatin-Induced Ototoxicity

Pedmark (sodium thiosulfate) is a cisplatin neutralizing agent in development for the protection against hearing loss in pediatric patients receiving cisplatin chemotherapy.

Development Timeline for Pedmark

DateArticle
Apr 27, 2022Fennec Pharmaceuticals Announces FDA Acceptance for Filing of New Drug Application Resubmission for Pedmark
Mar 24, 2022Fennec Pharmaceuticals Resubmits New Drug Application to U.S. Food And Drug Administration for Pedmark
Nov 29, 2021Fennec Pharmaceuticals Expects to Receive Complete Response Letter from the FDA for its New Drug Application for Pedmarkā„¢ to Prevent Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors
Jun 22, 2021Fennec Pharmaceuticals Announces FDA Acceptance of New Drug Application Resubmission for Pedmark
May 28, 2021Fennec Pharmaceuticals Resubmits New Drug Application To U.S. Food And Drug Administration For Pedmark
Aug 11, 2020Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for Pedmark to Prevent Ototoxicity Associated With Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors
Dec 20, 2018Fennec Pharmaceuticals Initiates Rolling New Drug Application to FDA for Pedmark
Mar 22, 2018Fennec Pharmaceuticals Receives Fast Track Designation by FDA for Pedmark

Further information

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