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FDA Accepts Alkermes Resubmission of New Drug Application for ALKS 3831 - FDA Sets PDUFA Target Action Date of June 1, 2021 - DUBLIN, Dec. 29, 2020 /PRNewswire/ Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company s New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder, and has assigned the application a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021. The FDA classified the resubmission as a complete, Class 2 response to the Complete Response Letter (CRL) issued in November 2020, following a remote review of records requested under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FDCA ) relating to the manufacture of ALKS 3831 at the company s Wilmington, OH facility. Subsequent to Alkermes resubmission of the NDA, the FDA issued a new request

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