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.
Tag Archive for: Hetlioz
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.
Vanda Pharmaceuticals has prevailed in its case against the FDA. On Monday, a federal court sided in favor of Vanda in its Freedom of Information Act case against the agency regarding its sleep drug label expansion.