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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...
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.
Read also: Ajanta Pharma Gets CDSCO panel conditional Nod to Manufacture, Market Cardiovascular FDC Drug
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751