Lupin’s U.S. subsidiary receives USFDA tentative approval for its Pregabalin Capsules

07 Jul 2011 Evaluate

Pharma Major, Lupin’s U.S. subsidiary - Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for its Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg from the United States Food and Drugs Administration (USFDA’s) for the Company’s Abbreviated New Drug Application (ANDA) to market a generic version of C.P. Pharmaceuticals C.V., LYRICA (Pregabalin) capsules.

Lupin’s Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg are the AB-rated generic equivalent of LYRICA capsules, which is indicated for neuropathic pain associated with diabetic peripheral neuropathy, post herpetic neuralgia, adjunctive therapy for adult patients with partial onset seizures and fibromyalgia.

LYRICA capsules had annual U.S sales of approximately $1.7 billion for the twelve months ending March 2011, based on IMS Health sales data.

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