Zydus Lifesciences’ U.S. subsidiary -- Zydus Pharmaceuticals (USA) Inc. 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 (USRLD: Trokendi XR). 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).
Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.
