PR Newswire
WASHINGTON, June 15, 2016
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 Kelly
Senior Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
Media Contact:
Alexandra Peterson
Senior Vice President, Health Practice Leader
Makovsky
(212) 508-9709
apeterson@makovsky.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/fda-grants-fanapt-three-years-of-marketing-exclusivity-for-labeling-changes-relating-to-maintenance-treatment-of-schizophrenia-300284868.html
SOURCE Vanda Pharmaceuticals Inc.