NDA resubmission for Pedmark for prevention of platinum-induced ototoxicity in solid tumors

However, a few days later, the FDA issued a complete response letter to Fennec Pharmaceuticals, the drug developer, after a pre-approval inspection of the manufacturing facility for sodium thiosulfate revealed deficiencies that resulted in a Form 483, which detailed conditions or practices that needed to be addressed before the agent could receive approval. After receipt of the final minutes from a Type A meeting with the FDA, the NDA for Pedmark was resubmitted to the FDA in June 2021. The application was accepted by the agency later that month for filing. However, in November 2021, a second CRL was issued to the company after manufacturing deficiencies were still identified.The target action date for the current NDA is September 23, 2022, under the Prescription Drug User Fee Act.