Amneal Pharmaceuticals: FDA Requests Additional Information on IPX203 Ingredient
03 Julho 2023 - 5:13PM
Dow Jones News
By Denny Jacob
Amneal Pharmaceuticals on Monday said it received a request from
the Food and Drug Administration for additional information
regarding an ingredient in IPX203, a Parkinson's disease treatment
for which the company submitted a new drug application.
The pharmaceutical company said the complete response letter
indicated a scientific bridge wasn't adequately established in
carbidopa while one was adequately established for the safety of
levodopa based on pharmacokinetic studies. It added that the letter
didn't identify issues regarding the efficacy or manufacturing of
IPX203.
Amneal Pharmaceuticals said it would work with the FDA to
address the comments and plans to meet with the agency to align on
the best path forward.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
July 03, 2023 15:58 ET (19:58 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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