Pharma major Ranbaxy Laboratories Ltd on Friday said it has received tentative approval from the US Food and Drug Administration to manufacture and market 25 mg, 100 mg and 200 mg Topiramate tablets.
"This tentative approval will add another product offering to our ever-expanding portfolio, that will provide patients and prescribers with an affordable, generic alternative o the brand," Jim Meehan, vice-president (sales and marketing), Ranbaxy Pharmaceuticals Inc, said.
Ranbaxy's Topiramate would be available after final approval by the USFDA, he added.
Topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients in the age group of 2-16 years, with partial onset seizures or primary generalized tonic-clonic seizures, the statement said.
Florida-basd RPI is a wholly-owned subsidiary of Ranbaxy Laboratries Ltd.
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