By: IPP Bureau
Last updated : January 07, 2023 9:39 am
Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.
Zydus Lifesciences Limited's (formerly known as Cadila Healthcare Limited) subsidiary Zydus Pharmaceuticals (USA) Inc. (Zydus) has launched Topiramate Extended-Release Capsules.
The company had earlier received final approval from the United States Food and Drug Administration (USFDA) to market Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg.
Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.
Topiramate Extended-Release capsule is indicated for Epilepsy: initial monotherapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures; adjunctive therapy in patients 6 years of age and older with partial onset, primary generalized tonic-clonic seizures, or seizures associated with Lenox-Gastaut Syndrome (LGS). It is also indicated for prophylaxis of migraine in patients 12 years of age and older.
Topiramate Extended-Release capsule had annual sales of USD 488mn in the United States according to IQVIA data (IQVIA MAT Nov. 2022).