Published: Jun 01, 2021 By Mark Terry The U.S. Food and Drug Administration (FDA)is starting off the summer months with a busy week after the Memorial Day holiday in the U.S. Here’s a look. Alkermes’ Drug for Schizophrenia and Bipolar I Disorder target action date of June 1, 2021, for its New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for adults with schizophrenia and adults with bipolar I disorder. The FDA classified the resubmission as a complete, Class 2 response to the Complete Response Letter (CRL) it issuedto Alkermes in November 2020. The CRL was issued related to a remote review of records requested under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act related to the company’s Wilmington, Ohio facility that manufactured the drug. There were no issues about clinical or non-clinical data in the NDA.