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news.Mylan Laboratories has received final approval from the FDA for its abbreviated new drug application to manufacture and market a generic version of Pfizer's antidepressant Zoloft.
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Sertraline hydrochloride tablets are the generic version of Zoloft and have been approved in 25mg, 50mg and 100mg strengths.
Pfizer's Zoloft had US sales of approximately $2.9 billion for the same strengths in the 12-month period ending December 31, 2006 according to IMS Health.
The FDA issued final approval following the expiration of Teva Pharmaceuticals' 180-days of marketing exclusivity, as provided for under the Hatch-Waxman Act.
Teva Pharmaceutical had been given exclusive rights to market the generic forms of Zoloft for the past six months.
Mylan said it intends to launch its product immediately.