Jan 2 2007
Lupin Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Sertraline Hydrochloride Tablets, 25mg, 50mg and 100mg.
Final approval is expected upon the expiration of the first ANDA filer's 180-day marketing exclusivity in February 2007.
Upon final approval, Lupin's Sertraline Tablets will be the AB-rated generic equivalent of Pfizer's ZOLOFT(R) Tablets, indicated for the treatment of major depressive disorder. The brand product had annual sales of approximately $3.1 billion for the twelve months ended July 2006, based on IMS sales data.
Headquartered in Mumbai, Lupin Ltd. is a leading pharmaceutical company with a strong research focus. It has a program for developing New Chemical Entities. The Company has a state-of-the-art R&D center in Pune. The Company is a leading global player in Anti-TB, Cephalosporins (anti-infectives) and Cardiovascular drugs (prils and statins) and has a notable presence in the areas of diabetology, NSAIDs and Asthma.
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