Lupin’s subsidiary receives USFDA approval for Generic LYRICA capsules

05 Jul 2012 Evaluate

Lupin’s subsidiary - Lupin Pharmaceuticals Inc. (collectively Lupin) has received final approval for its Pergabalin capsules, 0.25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg from United States Food Drugs Administration (FDA) to market a generic version of CP Pharmaceuticals C.V.LYRICA (Pregabalin) capsules.

Lupin's Pergabalin capsules 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg 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 US sales of approximately $1.8 billion for the twelve months ending March 2012, as per IMS Health sales data.

Lupin has a vibrant presence in the Indian pharmaceuticals market and has over the past several years made major strides in expanding its therapy portfolio. The company has a robust promotion and distribution setup along with a strong presence in various therapeutic areas, including the fast growing diabetes market.

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