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Published on 29 May 2008

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Satavaptan application withdrawn

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A leading pharmaceutical company has withdrawn its application for a marketing authorisation for the medicine Aquilda (satavaptan).

The 5mg and 25mg film-coated tablets were intended to be used to treat euvolaemic and hypervolaemic dilutional hyponatraemia, a metabolic condition in which the body’s blood sodium level falls below normal.

The European Medicines Agency (EMEA) received formal notification from Sanofi-aventis of its decision to withdraw the application after it was announced that the drug was under review.

Sanofi-aventis stated that the withdrawal of Aquilda was based on the request of the EMEA’s Committee for Medicinal Products for Human Use for additional information on the therapeutic safety and efficacy of satavaptan, the agency revealed.

The company said that it is currently developing this information but that the results will not be available before 2009. Withdrawal of the application does not prevent Sanofi-aventis from making a new application at a later stage.

More information about Aquilda and the state of the scientific assessment at the time of withdrawal will be made available in a document to be published on the EMEA website in due course.

Copyright © PA Business 2008

European Medicines Agency



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