Amneal: Receives FDA Complete Response Letter For IPX203; Requests Additional Pharmacokinetic Data

(RTTNews) - Amneal Pharmaceuticals, Inc. (AMRX) said the company has received a Complete Response Letter from the FDA regarding the New Drug Application for IPX203 for the treatment of Parkinson's disease. The letter stated 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.

Amneal Pharma said this does not impact the company's 2023 financial guidance, which did not include IPX203 revenues.

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