FDA approves new 300mg loading dose tablet for PLAVIX® (clopidogrel bisulfate)

Sanofi-aventis and Bristol-Myers Squibb Company announced today that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for a 300mg tablet of the antiplatelet PLAVIX® (clopidogrel bisulfate). The PLAVIX 300mg tablet will facilitate the use of the FDA-approved loading dose for appropriate acute coronary syndrome (ACS) patients as soon as possible after hospital admission. Acute ST-segment elevation myocardial infarction (STEMI), along with unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI), are the three conditions classified as ACS, a major cause of emergency medical care and hospitalization in the United States.

"The American College of Cardiology-American Heart Association treatment guidelines for UA/NSTEMI and the American Heart Association Cardiopulmonary Resuscitation and Emergency Cardiac Care guidelines for ACS patients (August 2007) recommend a 300mg loading dose of clopidogrel in conjunction with ASA (aspirin), yet many appropriate ACS patients do not receive a loading dose of clopidogrel," said Dr. Marc Cohen, F.A.C.C., Chief of the Division of Cardiology, and Director of the Cardiology fellowship at the Newark Beth Israel Medical Center and Professor of Medicine at the Mount Sinai School of Medicine.

"The 300mg loading dose has been proven effective in a broad ACS patient population," said Cohen. "A broad ACS population includes not only UA and NSTEMI, but also STEMI as supported by CURE, CLARITY and COMMIT trials."

The 300mg tablet is bioequivalent to four 75mg FDA approved tablets of PLAVIX. The 300mg tablet of clopidogrel will be available in the U.S. later this year and is also currently under European Medicines Evaluation Agency
(EMEA) review.