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
jim.kelly@vandapharma.com

SOURCE Vanda Pharmaceuticals Inc.


These press releases may also interest you

at 04:00
FOR MEDICAL AND TRADE MEDIA ONLY   Janssen's guselkumab is the first biologic to be approved that selectively blocks interleukin (IL)-23    Janssen-Cilag International NV announced today that the European Commission (EC) has approved TREMFYA®...

at 03:50
Flagship investment funds to focus on larger deals, and lead or co-lead the majority of deals New investment capabilities in healthcare and mezzanine debt added to business $10 billion in total AUM targeted by 2020 with growing investor base and new...

at 03:22
The "New Era of AI Leads the Future of the Cloud" themed Artificial Intelligence Summit was held in Nansha District, Guangzhou, China on November 17, 2017, as part of the local government's efforts to further promote the development of a new sector...

at 03:00
Hanson Wade, the London-based life sciences knowledge services specialist, has launched IO Combination Trials Intelligence (www.beacon-intelligence.com), to provide clarity to scientists and strategists in the booming immuno-oncology combination...

at 03:00
Atlantis Healthcare, global leader in outcomes-driven healthcare solutions, is proud to have won two awards for its 'On Path' program at last week's PMEA pharmaceutical industry awards. This innovative patient support program (PSP) was developed in...

at 02:00
Eminent researcher Dr Moosajee will address the Emirates Society of Ophthalmology Conference in Dubai Dr. Mariya Moosajee, MBBS BSc PhD FRCOphth, Consultant Ophthalmologist from Moorfields Eye Hospital London and an eminent researcher...




News published on 10 november 2017 at 16:05 and distributed by: