Cadila Healthcare gets USFDA nod for its Topiramate Capsules

Cadila Healthcare, the parent company of the Zydus Cadila group, has finally secured approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate capsules.

Topiramate drug is indicated as an initial monotherapy in patients 10 years old or older with partial onset or primary generalized tonic-clonic seizures.

In addition, the drug is also indicated as an adjunctive therapy for adults and pediatric patients aged 2 - 16 with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age or older with seizures associated with Lennox-Gastaut syndrome.

The company received the permission from the authority for Topiramate Capsules in the strengths of 15 mg and 25 mg respectively.