Fanapt iloperidone regulatory update

Vanda said in its 3Q12 earnings that it expects an oral hearing in the EU this month regarding the review of an MAA for iloperidone to treat schizophrenia. Vanda disclosed in its 2Q12 earnings that it requested an extension to submit responses to Day 180 questions from EMA's CHMP related to the review of the MAA (see BioCentury, Aug. 13). The serotonin (5-HT2) receptor and dopamine receptor antagonist is marketed in the U.S. as Fanapt for the indication by partner Novartis and is approved in Israel for the indication. Vanda also said in its 3Q12 earnings that Argentina approved the product. ...