The FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Clopidogrel tablets USP, 75mg and 300mg.
The generic version of Sanofi-Aventis' Plavix is indicated for acute coronary syndrome and for patients with a recent history of myocardial infarction, stroke or established peripheral arterial disease.
The company has begun the shipment of the product and was granted 180 days of marketing exclusivity for Clopidogrel Tablets, 300mg.
Mylan Pharmaceuticals will supply 75mg strength of this product in bottle form where as Mylan Institutional will supply the 300mg strength exclusively in unit dose packs of 30.
Mylan Institutional also will supply Clopidogrel Tablets, 75mg, in unit dose packs of 100, the company said.
According to IMS Health, Plavix Tablets, 75mg and 300mg, had approximately $6.7bn for the 12 months ending 31 March 2012 in the US.