The largest community of pharma leaders

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.


Recent Articles