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

PR Newswire

WASHINGTON, July 21, 2017

WASHINGTON, July 21, 2017 /PRNewswire/ – Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) announced today that the European Medicines Agency’s Committee for Medicinal Product for Human Use (CHMP) has adopted a negative opinion recommending against the marketing authorization of Fanaptum™ (oral iloperidone tablets) for the treatment of schizophrenia in adult patients in the European Union. The CHMP was of the opinion that the benefits of Fanaptum™ did not outweigh its risks and recommended against marketing authorization. Vanda intends to appeal this opinion and request a re-examination by the CHMP.

http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=231064#.WXIEEFGQzIU

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