Ajanta gets US FDA approval for Topiramate ER Capsules

Ajanta Pharma 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. 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 two tentative approvals and 22 ANDAs are awaiting US FDA approvals.