Update on NDA for roluperidone for the treatment of negative symptoms in schizophrenia.- Minerva Neurosciences Inc.
Minerva Neurosciences, Inc. announced that on May 8, 2023, it received confirmation from the FDA that the Company’s New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia has been filed in accordance with the recent Appeal Granted letter dated April 27, 2023 and assigned a standard review classification.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024.
The FDA advised that it identified potential review issues that had been previously cited in the refuse-to-file decision letter, which included those discussed at the Type C meeting in March 2022.
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