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Classified in: Health, Science and technology
Subject: EGV

Vanda Receives Negative Opinion for Marketing Authorization from the European Medicines Agency on Fanaptumtm for the Treatment of Schizophrenia



WASHINGTON, Nov. 10, 2017 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) announced today the refusal of the marketing authorization application (MAA) of Fanaptumtm (oral iloperidone tablets) for the treatment of schizophrenia in adult patients in the European Union.  In July 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the Fanaptumtm MAA. Vanda requested a re-examination of the initial opinion. After considering the grounds for this request, the CHMP re-examined the opinion and confirmed the refusal of the Fanaptumtm MAA on November 9, 2017.

About Vanda Pharmaceuticals Inc.
Vanda is a global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients.  For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com.

About Fanapt®

For full U.S. Prescribing Information for Fanapt®, including indication, Boxed Warnings and Important Safety Information, visit our Web site at www.fanapt.com.

Investor Contact:
Jim Kelly
Executive Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com

SOURCE Vanda Pharmaceuticals Inc.


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News published on 10 november 2017 at 16:05 and distributed by: