FDA Grants Fanapt® Three Years of Marketing Exclusivity for Labeling Changes Relating to Maintenance Treatment of Schizophrenia
WASHINGTON, June 15, 2016 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that the U.S. 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.
About Vanda Pharmaceuticals Inc. 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. For more on Vanda, please visit www.vandapharma.com.
Corporate Contact:Jim KellySenior Vice President and Chief Financial Officer Vanda Pharmaceuticals Inc. (202) firstname.lastname@example.org
Media Contact: Alexandra Peterson Senior Vice President, Health Practice LeaderMakovsky (212) 508-9709 email@example.com
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SOURCE Vanda Pharmaceuticals Inc.