Category: Parkinson’s News


Amneal Announces Complete Response Resubmission for IPX203 New Drug Application

BRIDGEWATER, N.J., Feb. 08, 2024 (GLOBE NEWSWIRE) — 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