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Lupin receives US FDA nod for lamotrigene tabs

Our Bureau, MumbaiFriday, June 4, 2010, 08:00 Hrs  [IST]

Lupin Limited's US subsidiary, Lupin Pharmaceuticals, Inc (LPI) has received the final approval for the company's Abbreviated New Drug Application (ANDA) for its lamotrigene tablets, 25 mg, 100 mg, 150 mg and 200 mg strengths, from the US Food and Drug Administration. Lupin's Lamotrigene is the AB-rated generic equivalent of GlaxoSmithKline's Lamictal tablets indicated for the maintenance treatment of bipolar I disorder and is also indicated as adjunctive therapy for specific seizure types. Lamictal tablets had annual sales of approximately US$ 452 million for the twelve months ended march 2010 (IMS Health).

 
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