European regulators have revealed that Sanofi-Aventis and Bristol-Myers Squibb have withdrawn a marketing authorisation application for a drug which combines the blockbuster Plavix with aspirin.
The European Medicines Agency said it had been formally notified by the firms’ decision to withdraw its application for DuoPlavin (clopidogrel/acetylsalicylic acid), which was expected to be used by patients already taking clopidogrel (Plavix) and acetylsalicylic acid (aspirin) for the prevention of atherothrombotic events in acute coronary syndrome. The application was submitted to the EMEA on May 30 and was under review by the agency's Committee for Medicinal Products for Human Use (CHMP).
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