sanofi-aventis and Bristol-Myers Squibb Company jointly announced that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for a 300 mg tablet of the antiplatelet Plavix (clopidogrel bisulfate).

The Plavix 300 mg 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, according to a company press release. 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 300 mg loading dose has been proven effective in a broad ACS patient population A broad ACS population includes not only UA and NSTEMI, but also STEMI as supported by cure, clarity and commit trials," added Cohen.

The 300 mg tablet is bioequivalent to four-75 mg 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, said the press release.

Plavix is a prescription antiplatelet medicine taken once a day that helps keep platelets in the blood from sticking together and forming clots. Since its initial approval on November 17, 1997, by the US Food and Drug Administration, Plavix has been prescribed to more than 52 million patients worldwide. The new 300mg loading dose tablet reinforces the strong commitment of two research and development pharmaceutical companies dedicated to improving patient health.

The efficacy and safety of Plavix have been established through four landmark clinical trials involving more than 81,000 patients. Plavix is the only widely available prescription antiplatelet that provides proven protection against a future heart attack or stroke for patients with ACS (UA, NSTEMI, STEMI) and recent MI, recent Stroke, or established peripheral artery disease, said the company.

Plavix has demonstrated early and long-term risk reduction for patients at risk for atherothrombotic events in important clinical trials. In the Cure trial, patients with unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI) receiving Plavix with aspirin were followed for up to one year, and in the Caprie trial, patients with recent MI, recent ischemic stroke, or established peripheral artery disease receiving Plavix alone were followed for up to three years.

Plavix is marketed worldwide by sanofi-aventis and Bristol-Myers Squibb Company as Plavix and Iscover.