Lupin gets FDA approval for Lyrica generic

Mumbai: Pharma major Lupin's subsidiary, Lupin Pharmaceuticals, 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 US Food and Drugs Administration (FDA) to market a generic version of C P Pharmaceuticals' 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 US sales of approximately $1.8 billion for the twelve months ending March 2012, according to IMS Health Sales Data.