> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Accepts Fennec Pedmark NDA Resubmission
- URL: https://www.fdaweb.com/fda-accepts-fennec-pedmark-nda-resubmission/
- Published: 2021-06-22T12:00:00.000Z
- Updated: 2026-09-14T17:04:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149596

FDA has accepted for filing Fennec Pharmaceuticals’ resubmission of an NDA for Pedmark, described as a unique formulation of sodium thiosulfate for preventing ototoxicity induced by cisplatin chemotherapy in patients one month to less than 18 years of age with localized, non-metastatic solid tumors. The company [says](https://www.marketwatch.com/press-release/fennec-pharmaceuticals-announces-fda-acceptance-of-new-drug-application-resubmission-for-pedmarktm-2021-06-22?tesla=y&ref=fdaweb.com) the PDUFA action date has been set for 11/27.

The drug has been granted both fast track and breakthrough therapy designations from FDA. Fennec says an 8/10/20 complete response letter referred to deficiencies with the facility of the drug product manufacturer without any clinical safety or efficacy issue and no requirement for further clinical data.