Lupin Limited, announced today that its subsidiary in the US, Lupin Pharmaceuticals, Inc. (LPI) has received final approval for the Company’s Abbreviated New Drug Application (ANDA) for Divalproex Sodium Delayed-Release Tablets, 125 mg, 250 mg and 500 mg from the U.S. Food and Drug Administration (USFDA). Commercial shipments of the product have already commenced.

Lupin’s Divalproex sodium delayed-release tablets are the AB-rated generic equivalent of Abbott Laboratories’ Depakote® tablets. Depakote had annual sales of approximately $803 million for the twelve months ended March 2008, based on IMS Health sales data.

With the approval of Divalproex Sodium Delayed-Release Tablets, the cumulative ANDA approvals of the Company stand at 31 (including 3 tentative approvals) with 34 pending approvals from the USFDA. 

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