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

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Published:2nd May 2022

The FDA has accepted for filing the new drug application (NDA) resubmission for a unique formulation of sodium thiosulfate (Pedmark) for the prevention of platinum-induced ototoxicity in patients between the ages of 1 month and 18 years who have localized, nonmetastatic, solid tumors.The first NDA submission for the agent received a priority review designation from the regulatory agency in August 2020.

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.

Condition: Cisplatin-induced Hearing Loss
Type: drug

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