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Company Watch
Lupin receives USFDA approval for Sertraline
Our News Bureau - Mumbai
Lupin
announced that the USFDA has approved the company's Abbreviated New Drug Application
(ANDA) for Sertraline Hydrochloride Tablets, 25 mg, 50 mg and 100 mg. Sertraline
Hydrochloride is indicated for the treatment of major depressive disorder. Lupin's
Sertraline Tablets are the AB-rated generic equivalent of Pfizer's Zoloft Tablets.
The branded product had annual sales of approximately $2.1 billion for the 12-month
period ended December 2006, according to IMS Health. With this approval, Lupin
now has 18 ANDAs approved by the USFDA.
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