Amneal Announces Complete Response Resubmission for IPX203 New Drug Application

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Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced that it has provided a Complete Response resubmission to the U.S. Food and Drug Administration (FDA) for IPX203, a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for the treatment of Parkinson’s disease (PD).

The original NDA for IPX203 resulted in a Complete Response Letter (CRL) from FDA. The resubmission package included data from a healthy volunteer study which was conducted in the fourth quarter of 2023. The FDA did not request any other studies.

“We are pleased to provide our complete response resubmission for IPX203 as we look to expand our Parkinson’s franchise,” said Chirag and Chintu Patel, Co-Chief Executive Officers at Amneal. “We look forward to launching this much-needed treatment in the second half of 2024, subject to FDA approval.”

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