Vanda Pharmaceuticals Inc. (Vanda), a specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has granted three years of marketing exclusivity for the changes related to the supplemental New Drug Application (sNDA) that was recently approved by FDA.
On May 26, 2016, Vanda announced that FDA had approved Vanda's sNDA for Fanapt, modifying and expanding the prescribing information for the use of Fanapt as a maintenance treatment of schizophrenia in adults.
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.
Vanda is a specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients.