Sun Pharmaceutical Industries Ltd announced that US FDA has granted an approval for its Abbreviated New Drug Application (ANDA) to market generic Topamax (topiramate) tablets.
These topiramate tablets are therapeutically equivalent to Topamax tablets from Ortho-McNeil Janssen Pharmaceuticals, Inc and are available in four strengths: 25 mg, 50 mg, 100 mg, and 200 mg. These strengths of Topamax tablets have annual sales of approximately USD 2.5 billion in the US.
Topiramate, an anticonvulsant is indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. It is also indicated as adjunctive therapy for adults and paediatric patients ages 2-16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients two years of age and older with seizures associated with Lennox-Gastaut syndrome.
Shipment of this product has commenced, a company press release stated.