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).
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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