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Home Industry News Bristol Myers Squibb receives FDA approval for Plavix loading dose tablet

Bristol Myers Squibb receives FDA approval for Plavix loading dose tablet

28th September 2007

Bristol-Myers Squibb (BMS) has announced that its 300mg loading dose tablet for Plavix (clopidogrel bisulfate) has been approved a supplemental new drug application (sNDA) by the US Food and Drug Administration (FDA).

Acute coronary syndrome (ACS) patients will now receive the 300mg tablet as soon as possible when admitted to hospital in order to facilitate the use of the FDA approved loading dose.

ACS can compose of three possible conditions including Acute ST-segment elevation myocardial infarction (STEMI), as well as unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI).

Dr Marc Cohen, chief of the division of cardiology, illustrated that many ACS patients do not receive a loading dose of clopidogrel despite guidelines set out by the American College of Cardiology-American Heart Association for treatment of UA and NESTMI recommending a 300mg loading dose of clopidogrel in conjunction with ASA (aspirin).

He confirmed: “The 300mg loading dose has been proven effective in a broad ACS patient population.”

The 300mg tablet of clopidogrel is currently under European Medicines Evaluation Agency (EMEA) review but will be available at some point in 2007 in the US.

Earlier this year, BMS was forced to pay a $1 million (494,000 pounds) fine after an investigation by the US Department of Justice into the company’s settlement with Apotex Inc and Apotex Corp concerning the launch of a generic version of Plavix

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