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
|Apr 27, 2022||Fennec Pharmaceuticals Announces FDA Acceptance for Filing of New Drug Application Resubmission for Pedmark|
|Mar 24, 2022||Fennec Pharmaceuticals Resubmits New Drug Application to U.S. Food And Drug Administration for Pedmark|
|Nov 29, 2021||Fennec Pharmaceuticals Expects to Receive 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|
|Jun 22, 2021||Fennec Pharmaceuticals Announces FDA Acceptance of New Drug Application Resubmission for Pedmark|
|May 28, 2021||Fennec Pharmaceuticals Resubmits New Drug Application To U.S. Food And Drug Administration For Pedmark|
|Aug 11, 2020||Fennec 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, 2018||Fennec Pharmaceuticals Initiates Rolling New Drug Application to FDA for Pedmark|
|Mar 22, 2018||Fennec Pharmaceuticals Receives Fast Track Designation by FDA for Pedmark|
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