Zydus Lifesciences gets USFDA final approval for Topiramate Capsules

1 Dec 2022 , 09:16 AM

Zydus Lifesciences Limited (formerly Cadila Healthcare) has got the United States Food and Drug Administration (USFDA) final approval to market Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg.

Topiramate Extended-Release capsule is used to treat and prevent seizures in people who have epilepsy. It can also be used to prevent migraines. The drug will be produced at the group’s formulation manufacturing facility in Ahmedabad Special Economic Zone, India.

According to IQVIA data, Topiramate Extended-Release capsule had annual sales of USD 68.8 million in the United States.

Since the beginning of the filing process in FY 2003-04, the group has received 335 approvals and has filed over 431 ANDAs.

At around 9.18 AM, Zydus Lifesciences was trading at Rs412 up by 0.62% from its previous closing of Rs409.45 on the BSE.

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