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Home Industry News Sanofi Aventis files patent, safety action

Sanofi Aventis files patent, safety action

29th May 2008

An application by a drug company for approval of clopidogrel besylate has been challenged by Sanofi-Aventis (SA).

It says more than 70 million patients around the world have been treated with Plavix (clopidogrel bisulfate), an anti-platelet medication.

The new application by a company SA did not identify included registrations that have been acquired in “violation of applicable laws”, it said.

Among its concerns is that the registrations referred to a salt different to that used in Plavix and the information on indications is “limited”.

“Anti-platelet agents need rigorous evaluation through well designed clinical trials in patients, before concluding on the efficacy and the safety profile of such compounds,” the company stated.

It noted Plavix had undergone several studies that included more than 100,000 people.

The application for clopidogrel besylate has been lodged with the German drugs regulatory authority.

Plavix is taken daily by patients at risk of blood clots and can be taken with aspirin.

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