Lowers the risk of ototoxicity associated with cisplatin. NDA 212937, held by Fennec Pharms Inc. Sodium Thiosulfate.
As of Nov 13, 2026, NDA 212937 (Pedmark), held by Fennec Pharms Inc, was first approved by FDA on Sep 20, 2022, with 0 approved supplements and 2 published complete response letters.
PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. Limitations of Use The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 20, 2022 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Nov 26, 2021 | PEDMARK (sodium thiosulfate injection)Facility Inspections And Manufacturing Processes, Clinical | Approved |
| Aug 10, 2020 | PEDMARK (sodium thiosulfate injection)Product Quality, Facility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pedmark12.5GM/100ML (125MG/ML) · solution;intravenous | Sodium Thiosulfate | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
