Alkermes reported this week that its treatment for schizophrenia and bipolar disorder has been rejected by the FDA.
The agency flagged manufacturing issues related to how the company coats the tablets as the reason for not approving the treatment, ALKS 3831.
Aklermes says that it has already resolved the agency’s manufacturing observations and that they only applied to certain batches of the drug. The company says it has sufficient data on the manufacturing issue and is now working with the FDA to resubmit its application.
Read the Reuters report.
