Vanda Receives Negative Opinion for Marketing Authorization from the European Medicines Agency on Fanaptum™ for the Treatment of Schizophrenia
2017-11-10 · Vanda Pharmaceuticals · original vandapharma.com ↗
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 [email protected] 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.
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