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
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) [email protected]
Media Contact: Alexandra Peterson Senior Vice President, Health Practice LeaderMakovsky (212) 508-9709 [email protected]
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.
Subscribe to our Free Newsletters!
Hand hygiene is a simple and affordable technique to prevent infections.
Erythropoietin is a hormone secreted by kidneys in response to low oxygen levels in tissues ...
Local anesthesia is a type of anesthesia generally used to block pain sensation only in a specific ...View All