Ranbaxy Laboratories Limited (RLL) announced today that the company has received tentative approval from the US 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 totalling $1,129 million (IMS - MAT: September 2004), a company release said.
Topiramate tablets are indicated as adjunctive therapy for adults and paediatric patient's 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 US FDA," according to Jim Meehan, vice president of sales and marketing for RPI, USA.