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# FDA Complete Response Letter for Alkermes Psych Drug
- URL: https://www.fdaweb.com/fda-complete-response-letter-for-alkermes-psych-drug/
- Published: 2020-11-17T12:00:00.000Z
- Updated: 2026-09-14T16:36:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148104

FDA has issued a complete response letter (CRL) for the Alkermes NDA for its ALKS 3831 (olanzapine/samidorphan) for treating adults with schizophrenia and bipolar 1 disorder. The letter indicates that FDA requires the resolution of certain conditions related to the tablet coating process at the firm’s Wilmington, OH, facility before the drug can be approved. Alkermes [says](https://www.prnewswire.com/news-releases/alkermes-receives-fda-complete-response-letter-related-to-alks-3831-manufacturing-records-review-301174254.html?ref=fdaweb.com) the letter did not identify or raise any concerns about the clinical or non-clinical data in the NDA and FDA has not asked the company to complete any new clinical trials to support approval of the application.

“The observations noted in the CRL were specific to certain development batches of ALKS 3831\. The company believes this issue has since been resolved and that sufficient data is available to address these observations,” the company says. “Alkermes is preparing these data for submission and plans to work closely with the agency to resolve these items in a timely manner and complete labeling discussions for the application.”