Vanda was seeking the health regulator’s nod for the drug tradipitant to treat gastroparesis, a condition characterized by delayed gastric emptying.
Tag Archive for: Vanda Pharmaceuticals
The U.S. Supreme Court on Monday declined to hear a bid by Vanda Pharmaceuticals to revive patents for its sleep-disorder drug Hetlioz that were previously declared invalid in a dispute with generic drugmakers Teva and Apotex.
The FDA on Tuesday approved the use of Vanda Pharmaceuticals’ atypical antipsychotic Fanapt (iloperidone) for the treatment of manic or mixed episodes in adult patients with bipolar I disorder.
The FDA will kick off March with three target action dates, including one for an insomnia treatment and another for a multiple sclerosis therapy.
Vanda told the U.S. Court of Federal Claims that the FDA gave confidential information about Fanapt and Hetlioz, its only two drugs, to generic competitors including Lupin Ltd., Apotex Inc. and Teva Pharmaceutical.