Amneal Receives U.S. FDA Complete Response Letter for IPX203

BRIDGEWATER, N.J.–(BUSINESS WIRE)–Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for IPX203 for the treatment of Parkinson’s disease. 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

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