WASHINGTON, Nov. 10, 2017 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) announced today the
refusal of the marketing authorization application (MAA) of
Fanaptum™ (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 Fanaptum™ 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 Fanaptum™ 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
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SOURCE Vanda Pharmaceuticals Inc.