Amneal Pharma: FDA To Evaluate NDA For IPX203 In Treatment Of Parkinson's Disease

(RTTNews) - Amneal Pharmaceuticals, Inc. (AMRX) announced the FDA has accepted for review the New Drug Application for IPX203 for the treatment of Parkinson's disease. The FDA assigned a PDUFA date of June 30, 2023 to complete its evaluation of the NDA.

Gustavo Pesquin, Chief Commercial Officer, Amneal Specialty, said: "We look forward to engaging in conversations with the FDA as we advance the application. We believe the data in our RISE-PD study supports the important benefit IPX203 can offer to this community by providing longer duration of symptom control with the benefit of fewer doses."

Shares of Amneal Pharmaceuticals are up 4% in pre-market trade on Friday.

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