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.
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[10-November-2017] |
WASHINGTON, Nov. 10, 2017 /PRNewswire/ -- 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. 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: View original content:http://www.prnewswire.com/news-releases/vanda-receives-negative-opinion-for-marketing-authorization-from-the-european-medicines-agency-on-fanaptum-for-the-treatment-of-schizophrenia-300554039.html SOURCE Vanda Pharmaceuticals Inc. | ||
Company Codes: NASDAQ-NMS:VNDA |