Ranbaxy Pharmaceuticals announced tentative approval from the U.S. Food and Drug Administration to manufacture and market Topiramate Tablets, 25 mg, 100 mg, and 200 mg. Total annual market sales for Topiramate were $1,184 million with sales of these three strengths of tablets totaling $1,129 million.
Topiramate Tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 - 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.
"This tentative approval for Topiramate Tablets will add another product offering to our ever-expanding product portfolio of CNS products, that will provide patients and prescribers with an affordable, generic alternative to the brand. Ranbaxy's Topiramate will be available following final approval by the U.S. FDA," according to Jim Meehan, Vice President of Sales and Marketing for RPI.
Ranbaxy Pharmaceuticals Inc. ("RPI") based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited ("RLL"), India's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.