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Lupin gets US FDA nod for lamotrigine tablets

This article was originally published in Scrip

Executive Summary

Lupin's US subsidiary has received final US FDA approval for its ANDA for lamotrigine 25mg, 100mg, 150mg and 200mg tablets, which are generic versions of GlaxoSmithKline's anticonvulsant, Lamictal tablets. Lupin's potential launch of its product comes well after Teva Pharmaceutical Industries introduced the first generic version of Lamictal tablets in 2008, following a settlement of patent litigation with GSK in February 2005. Under the settlement, GlaxoSmithKline granted Teva the exclusive right to manufacture and sell a generic version of Lamictal during the six-month paediatric exclusivity period, which ended on 22 January 2009. Lamictal tablets had sales of about $452 million for the 12 months ended March 2010, according to IMS Health. Teva launched lamotrigine chewable tablets (5mg and 25mg) in 2005, and the Indian company, Aurobindo Pharma, received final FDA approval for lamotrigine 5mg and 25mg chewable, dispersible tablets last November.



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