Ajanta Pharma bags USFDA nod for migraine drug Topiramate ER

Mumbai: Ajanta Pharma Limited, a speciality pharmaceutical formulation company, has received final approval from the United States Food and Drug Administration (USFDA) to market Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg and 200 mg.

Topiramate is the generic version of Supernus Pharmaceuticals Inc’s Trokendi XR. It is used for the treatment of seizures in people with epilepsy and to prevent migraine.

As per the settlement with the innovator, Ajanta can launch Topiramate on February 1, 2026 or earlier under certain circumstances. Ajanta has received 50 final ANDA approvals, out of which 41 are commercialized. Ajanta also holds 2 tentative approvals and 22 ANDAs are awaiting US FDA approvals.

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