Vanda Gets FDA Approval For Fanapt Marketing Exclusivity

Vanda Pharmaceuticals Inc. (Vanda)

revealed that the U.S. Food and Drug Administration (FDA) has granted three years of marketing exclusivity for the changes in respect of the supplemental New Drug Application (sNDA), which was recently approved by FDA. Vanda said that on May 26 it revealed FDA had approved its sNDA for Fanapt, modifying and expanding the prescribing information for the use of Fanapt as a maintenance treatment of schizophrenia in adults. The company indicated that the FDA added this entry to the Fanapt Orange Book listing providing exclusivity until May 26, 2019 based upon three years from the sNDA approval date. Shares of the company traded 0.32 percent lower on Tuesday.