Wyeth Europa Ltd Withdraws Its Marketing Authorisation Application For Ellefore For Major Depressive Disorder

Main Category: Depression
Also Included In: Psychology / Psychiatry;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 17 Oct 2008 - 1:00 PDT

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The European Medicines Agency (EMEA) has been formally notified by Wyeth Europa Ltd of its decision to withdraw the application for a centralised marketing authorisation for the medicine Ellefore (desvenlafaxine) 50 mg, 100 mg and 200 mg prolonged-release tablets.

Ellefore was expected to be used for the treatment of major depressive disorder.

The application for marketing authorisation for Ellefore was submitted to the EMEA on 28 September 2007. At the time of the withdrawal, it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP).

In its official letter, the company stated that the withdrawal of Ellefore was based on its decision not to continue with pan-European Union approval at this time.

More information about Ellefore and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the EMEA website in due course.

- Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.

European Medicines Agency
www.emea.europa.eu