Lupin Receives FDA Approval for Generic Lyrica

FDA Approves Generic Lyrica

MUMBAI and BALTIMORE, July 5, 2012/PRNewswire-FirstCall/ --Pharma major, Lupin Ltd., announced today that its subsidiary, Lupin Pharmaceuticals Inc. (collectively, Lupin) has received final 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 (FDA) 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 $1.8 billion for the twelve months ending March 2012 (IMS Health Sales Data).

Source: Lupin Limited

Posted: July 2012


View comments

Hide
(web5)