Wockhardt receives three FDA approvals

SILVER SPRING, Md. — Indian generic drug maker Wockhardt received three new drug approvals from the Food and Drug Administration, agency records show.

The FDA approved Wockhardt's generic version of Bristol-Myers Squibb's and Sanofi's blood-thinning drug Plavix (clopidogrel bisulfate) in the 75-mg and 300-mg strengths; bupropion hydrochloride extended-release tablets in the 150-mg strength, a generic version of GlaxoSmithKline's antidepressant Wellbutrin SR; and a generic version of Novartis' Parkinson's disease drug Stalevo (carbidopa, levodopa and entacapone) in the 18.75-mg/200-mg/75-mg, 25-mg/200-mg/100-mg, 31.25-mg/200-mg/150-mg, 37.5-mg/200-mg/150-mg and 50-mg/200-mg/200-mg strengths.

According to IMS Health, Plavix had sales of $6.8 billion in 2011, while Wellbutrin SR has sales of $268 million, and industry sources estimate Stalevo has sales of about $95 million.


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