Amneal Slides as FDA Asks for Data on Parkinson’s Treatment (1)

(Adds share move)

Amneal slips as much as 13% in post-market trading Monday after announcing it was asked for “additional pharmacokinetic data” on its Parkinson’s disease treatment, IPX203, in a Complete Response Letter from the FDA.

• No clinical efficacy or manufacturing issues identified
• “The letter indicated that although an adequate scientific bridge was established for the safety of one ingredient, levodopa (LD), based on pharmacokinetic studies, it was not adequately established for the other ingredient, carbidopa (CD), and FDA has requested additional information
• Plans to work with FDA to address request
• Does not impact 2023 guidance as it did not ...