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Sep 27 2007, 5:00 AM EST

FDA Approves New 300mg Loading Dose Tablet for PLAVIX(R) (clopidogrel bisulfate)

PRNEWSWIRE

BRIDGEWATER and PRINCETON, N.J., Sept. 27 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for a 300mg tablet of the antiplatelet PLAVIX(R) (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.

About PLAVIX

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 U.S. 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.

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 (Paris Bourse: EURONEXT: SAN; New York: NYSE: SNY) and Bristol-Myers Squibb Company (NYSE: BMY) as Plavix(R

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