WASHINGTON, DC, USA I July 21, 2017 I 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.
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.
SOURCE: Vanda Pharmaceuticals
Post Views: 29
WASHINGTON, DC, USA I July 21, 2017 I 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.
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.
SOURCE: Vanda Pharmaceuticals
Post Views: 29
