Amneal Pharmaceuticals receives FDA Complete Response Letter for IPX203

Amneal Pharmaceuticals announced it has received a Complete Response Letter, or CRL, from the FDA regarding the company’s New Drug Application, or NDA, for IPX203 for the treatment of Parkinson’s disease. The letter indicated that although an adequate scientific bridge was established for the safety of one ingredient, levodopa, based on pharmacokinetic studies, it was not adequately established for the other ingredient, carbidopa, and FDA has requested additional information. The letter did not identify any issues with respect to the efficacy or manufacturing of IPX203. Amneal will work closely with the FDA to address its comments and plans to meet with the agency to align on the best path forward. This does not impact Amneal’s 2023 financial guidance, which did not include IPX203 revenues.