Lupin Is Granted USFDA Approval For Levetiracetam Tablets
Lupin Pharmaceuticals, Inc. (LPI) announced recently that it has received final approval for the Company's Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets 250mg, 500mg, 750mg and 1000mg from the U.S. Food and Drug Administration (USFDA). Commercial shipments of the product have commenced.
Lupin's Levetiracetam tablets are the AB-rated generic equivalent of UCB Pharmaceuticals' Keppra® tablets, indicated as adjunctive therapy in the treatment of certain types of Seizures associated with Epilepsy. Keppra tablets had annual sales of approximately $1.2B (USD) for the twelve months ended September 2008, based on IMS Health sales data.
January 29, 2009