On Tuesday, Alkermes Plc. announced that the U.S. Food and Drug Administration (FDA) accepted the company's resubmission of its new drug application for its treatment of schizophrenia or bipolar 1 disorder.
The FDA classified the resubmission as a complete, Class 2 response to the Complete Response Letter (CRL) issued in November 2020. Last month, the FDA had turned away Alkermes’ ALKS 3831 candidate, since it had concerns with conditions related to the tablet-coating process.
Alkermes said it will continue to work closely with the FDA as it completes its review of ALKS 3831.
The pharma company said that it wants to make the treatment available to patients as soon as possible.