(Reuters) – The U.S. Food and Drug Administration has declined to approve Alkermes’ treatment for schizophrenia and bipolar disorder, the drugmaker said on Tuesday.
Following a remote review of manufacturing records, the FDA stated that resolution of certain conditions related to the tablet coating process at the company’s facility was required before the treatment can be approved.
(Reporting by Dania Nadeem in Bengaluru; Editing by Shinjini Ganguli)
