Benzinga | Jun 22, 2021 06:00AM EDT

Fennec Pharmaceuticals Announces FDA Acceptance Of New Drug Application Resubmission For PEDMARK

Fennec Pharmaceuticals Inc. (NASDAQ:FENC, TSX:FRX), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the resubmission of its New Drug Application (NDA) for PEDMARK(tm) (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 Prescription Drug User Fee Act (PDUFA) target action date has been set for November 27, 2021.

"We are pleased that the FDA has accepted our PEDMARK(tm) resubmission," said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals, Inc. "We look forward to working closely with the FDA through the review process. We are committed to bringing this treatment to children receiving cisplatin chemotherapy, an area of high unmet medical need. If approved, PEDMARK(tm) stands to be the first FDA approved therapy to reduce the risk of cisplatin induced ototoxicity in pediatric patients."

PEDMARK has been granted both Fast Track Designation and Breakthrough Therapy Designation by the FDA. 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.