Le Lézard
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
[email protected]

SOURCE Vanda Pharmaceuticals Inc.


These press releases may also interest you

at 17:31
White Glove Placement, a leading provider of staffing solutions for healthcare facilities, is proud to announce its "Scoops of Gratitude" Free Ice Cream Truck to celebrate Nurses Week and show appreciation for the dedication and hard work of nurses...

at 17:31
DelveInsight's Opioid Withdrawal...

at 17:30
Two El Camino Health hospitals in the South Bay have earned the highest ranking for patient safety from The Leapfrog Group, a national, not-for-profit, independent evaluator that measures excellence in patient care. This national distinction marks...

at 17:25
Myomo, Inc. ("Myomo" or the "Company"), a wearable medical robotics company that offers increased functionality for those suffering from neurological disorders and upper-limb paralysis, today announced that it will report financial results for the...

at 17:23
EVP Capital Inc. ("EVP Capital"), a capital pool company ("CPC") listed on the TSX Venture Exchange Inc. (the "Exchange"), is pleased to announce that it has entered into a non-binding letter of intent dated May 1, 2024 (the "LOI") with Sharp Edge...

at 17:01
Moonstone Nutrition, a pioneering nutraceutical company dedicated to the prevention of kidney stones, is thrilled to announce the launch of its latest investment campaign on StartEngine, one of the leading equity crowdfunding platforms. This exciting...



News published on and distributed by: