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Lupin, Glenmark and Orchid receive FDA OK for levetiracetam

This article was originally published in Scrip

Executive Summary

LupinPharmaceuticals, Glenmark Genericsand Orchid Chemicals and Pharmaceuticals, have received approval from the US FDA for levetiracetam 250mg, 500mg and 750mg tablets, generic versions of UCB Pharmaceuticals' anti-epileptic, Keppra tablets. Lupin has received approval for levetiracetam 1,000mg tablets and the company has begun commercial shipments of its products. Glenmark has commenced marketing and distribution of its generic versions in the US – it has a partnership with Invagen Pharmaceuticals for the product, under which Glenmark will exclusively market and distribute the product while Invagen is responsible for its manufacture and supply. Levetiracetam tablets had sales of about $1.2 billion in the 12 months ended September 2008. Glenmark now has 38 generic products authorised for distribution in the US, while Orchid's cumulative ANDA approval count now stands at 30.


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