Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Topiramate tablets, 25 mg, 50 mg, 100 mg and 200 mg from the U.S. Food and Drug Administration (USFDA).
Lupin's Topiramate tablets are the AB-rated generic equivalent of Ortho-McNeil's TOPAMAX(R) tablets, indicated for the treatment of seizures. The brand product had annual sales of approximately $2.2 billion for the twelve months ended March 2008, based on IMS Health sales data.
The details can be read here.
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