Vanda Pharmaceuticals (VNDA) has received a negative opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use regarding iloperidone for the treatment of schizophrenia and the acute treatment of manic or mixed episodes associated with bipolar disorder, the regulator said Friday.
The EMA recommended the refusal of marketing authorization for iloperidone and said Vanda may apply for a re-examination of the opinion within 15 days.