Fennec Pharma Resubmits Application to FDA for PEDMARK

 If Approved by the FDA, PEDMARK Stands to Be the First Therapy for the Prevention of Cisplatin-Induced Hearing Loss in Children ~

Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PEDMARK™ (a unique formulation of sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors.

The resubmission for PEDMARK follows receipt of final minutes from a Type A meeting with the FDA. Importantly, the Complete Response Letter (CRL) received on August 10, 2020 referred to deficiencies with the facility of the drug product manufacturer; no clinical safety or efficacy issues were identified and there was no requirement for further clinical data.

https://finance.yahoo.com/news/fennec-pharmaceuticals-resubmits-drug-application-100000229.html