Pharma major Lupin Ltd. said its US subsidiary Lupin Pharmaceuticals, Inc., has received tentative approval for its Pregabalin capsules, 25mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg strengths, from the US FDA for its Abbreviated New Drug Application or ANDA to market a generic version of C P Pharmaceuticals C V, Lyrica (Pregabalin) capsules.
Lupin's Pregabalin Capsules are indicated for neuropathic pain associated with diabetic peripheral neuropathy, post herpetic neuralgia, adjunctive therapy for adult patients with partial onset seizures and fibromyalgia.
As per IMS Health sales data, Lyrica capsules had sale of around $1.7 billion for the twelve months ended March 31 this year.