Sanofi-Aventis and Bristol-Myers Squibb have announced the approval of a supplemental New Drug Application (sNDA) for a 300mg tablet of clopidogrel bisulfate (Generic Plavix) for acute coronary syndrome (ACS) patients as soon as possible after hospital admission. Currently available as a 75-mg tablet taken once a day, generic clopidogrel helps to prevent platelets from sticking together and forming clots. It was initially approved in 1997.
Acute ST-segment elevation myocardial infarction (STEMI), along with unstable angina 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 U.S.
The 300-mg tablet will be available in the U.S. later this year. It is also under review in Europe.
(Source: Sanofi-Aventis, September 27, 2007.)