Ajanta Pharma receives USFDA for Topiramate Extended Release Capsules
Drug Approval

Ajanta Pharma receives USFDA for Topiramate Extended Release Capsules

Topiramate is the generic version of Supernus Pharmaceuticals’ Trokendi XR

  • By IPP Bureau | August 31, 2023

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’ 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 2 tentative approvals and 22 ANDAs are awaiting US FDA approvals.

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