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Alkermes Gets FDA Complete Response Letter On ALKS 3831 Manufacturing Records Review

Alkermes plc (ALKS) said Tuesday that it received a complete response letter from the U.S. Food and Drug Administration regarding its New Drug Application for ALKS 3831 or olanzapine/samidorphan for the treatment of adults with schizophrenia and adults with bipolar I disorder.

The company noted that the complete response letter did not identify or raise any concerns about the clinical or non-clinical data in the New Drug Application and the FDA has not asked Alkermes to complete any new clinical trials to support approval of the application.

FDA stated that resolution of certain conditions related to the tablet coating process at the company's Wilmington, OH facility is required before ALKS 3831 may be approved.

The observations noted in the CRL were specific to certain development batches of ALKS 3831. The company is preparing data for submission and plans to work closely with the Agency to resolve the items in a timely manner and complete labeling discussions for the application, Alkermes said in a statement.

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