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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
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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