Fennec Pharmaceuticals Inc. (NASDAQ:FENC) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing of resubmitted New Drug Application (NDA) for PEDMARKTM (sodium thiosulfate) for the prevention of platinum-induced ototoxicity in pediatric patients one month to less than 18 years of age with localized, non-metastatic, solid tumors.
The regulatory agency has set a target action date of September 23, 2022.
Rosty Raykov, chief executive officer, said, “We are pleased that the FDA has accepted our resubmission and we look forward to working with the Agency to facilitate their review of our NDA. If approved, PEDMARKTM has the potential to become a transformative treatment for pediatric patients at risk of cisplatin induced ototoxicity”.
FDA issued Complete Response Letter (CRL) in November, 2021 for the New Drug Application (NDA) for PEDMARK, as a result of identified manufacturing deficiencies.
FDA granted both Breakthrough Therapy and Fast Track Designation to PEDMARK.
Fennec Pharmaceuticals is trading up 2.24 percent at $6.40 in the pre-market session.
