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Amneal Reports Complete Response Resubmission To FDA For IPX203 New Drug Application

Author: Benzinga Newsdesk | February 08, 2024 05:13pm

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.

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