Sun Pharma on Sunday said the US Food and Drug Administration (FDA) has granted an approval for its abbreviated new drug application to market generic Topamax, topiramate tablets.
The shipment of the product to the US has commenced, Sun Pharma said in a statement.
These tablets are therapeutically equivalent to Topamax tablets from Ortho-McNeil Janssen Pharmaceuticals, the release said.
The tablets are available in 25 mg, 50 mg, 100 mg and 200 mg. Topamax tablets have annual sales of $2.5 billion in the US, Sun said.
Topiramate, an anticonvulsant, is indicated as initial monotherapy in patients of 10 years of age and older with partial onset or primary generalised tonic-clonic seizures.
It is indicated as adjunctive therapy for adults and paediatric patients with partial onset seizures or primary generalised tonic-clonic seizures, it said.