Ajanta Pharma gets USFDA’s final nod for Topiramate Extended-Release Capsules

30 Aug 2023 Evaluate

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. 

The company has received 50 final ANDA approvals, out of which 41 are commercialized. Ajanta also holds 2 tentative approvals and 22 ANDAs are awaiting USFDA approvals. 

Ajanta Pharma is a specialty pharmaceutical company engaged in development, manufacturing and marketing of quality finished dosages.

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