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news.The US Food and Drug Administration (FDA) has granted sanofi-aventis and Bristol-Myers Squibb an additional six month period of exclusivity to market PLAVIX (clopidogrel bisulfate).
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Exclusivity for PLAVIX in the US is now scheduled to expire on 17 May 2012.
According to sanofi-aventis and Bristol-Myers Squibb, PLAVIX has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.
For patients with ST-elevation myocardial infarction (STEMI), PLAVIX has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke.
The benefit for patients who undergo primary percutaneous coronary intervention is unknown.
The optimal duration of Plavix therapy in acute coronary syndrome is unknown.
PLAVIX has also been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.