By Colin Kellaher

Amneal Pharmaceuticals shares tumbled on Wednesday after the U.S. Food and Drug Administration turned away the company's application seeking approval of IPX203 for the treatment of Parkinson's disease.

Shares of the Bridgewater, N.J., pharmaceutical company were recently changing hands at $2.55, down more than 16%.

Amneal on Monday said it received a so-called complete response letter from the FDA related to IPX203, indicating the agency won't approve the application in its current form.

Amneal said the FDA requested additional information on carbidopa, one of the drug's ingredients, adding that the agency didn't identify any issues with respect to the efficacy or manufacturing of IPX203.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

July 05, 2023 10:21 ET (14:21 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.
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