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news.Sanofi Pharma Bristol-Myers Squibb has withdrawn its marketing authorisation for "DuoPlavin" and has formally notified The European Medicines Agency (EMEA) of the same. DuoPlavin, a fixed-dose combination tablets of 75mg clopidogrel/75 mg acetylsalicylic acid and 75mg clopidogrel/100 mg acetylsalicylic acid, for the treatment of atherothrombotic events in acute coronary syndrome.
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DuoPlavin can be taken along with clopidogrel and acetylsalicylic acid for the approved indication of prevention of atherothrombotic events in acute coronary syndrome, said the company.
Earlier, the application for marketing approval was submitted to EMEA on May 30, 2007. At the time of the withdrawal, it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).
The company has stated that the withdrawal of the application for DuoPlavin was based on the request of the CHMP, which has requested the need to document bioequivalence based on the current guideline on bioavailability and bioequivalence.
The company now plans to perform a new bioequivalence study, which will measure plasma levels of clopidogrel parent compound, to fulfill CHMP request.