Agency gives nod to new loading dose of Plavix

October 1, 2007

FDA approves 300-mg strength of clopidogrel

The FDA has approved a 300-mg tablet of clopidogrel (Plavix, Sanofi-Aventis/Bristol-Myers Squibb). A 300-mg loading dose was already approved by the agency for non-ST-segment elevation acute coronary syndrome (ACS) patients to be given as soon as possible following hospital admission. The recently updated ACC/AHA treatment guidelines for UA/NSTEMI and the AHA Cardiopulmonary Resuscitation and Emergency Cardiovascular Care guidelines for ACS patients also both recommend a 300-mg loading dose of clopidogrel in conjunction with aspirin. According to the manufacturers, the new 300-mg tablet is bioequivalent to four 75-mg tablets, the other available strength of clopidogrel.

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