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Lupin wins FDA approval for generic seizure drug

Lupin Pharmaceuticals, a wholly owned US subsidiary of India-based Lupin, has received final approval for the company's abbreviated new drug application for levetiracetam tablets 250mg, 500mg, 750mg and 1000mg from the FDA. Commercial shipments of the product have commenced.

Lupin’s levetiracetam tablets are the AB-rated generic equivalent of UCB Pharmaceuticals’s Keppra tablets, indicated as adjunctive therapy in the treatment of certain types of seizures associated with epilepsy.