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U.S. FDA declines to approve Alkermes’ schizophrenia treatment

(Reuters) – The U.S. Food and Drug Administration did not approve Alkermes’ treatment for schizophrenia and bipolar disorder, the drugmaker said on Tuesday.

Following a review, the FDA said the resolution of certain conditions related to a tablet coating process at the company’s facility was required before the treatment can be approved.

Source: https://www.reuters.com/article/us-alkermes-plc-fda/u-s-fda-declines-to-approve-alkermes-schizophrenia-treatment-idUSKBN27X1GI

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