Alembic Pharma Gets USFDA Nod for Generic Epilepsy Drug

28 Jul 2025 , 11:36 AM

Alembic Pharmaceuticals has secured final approval from the US Food and Drug Administration to sell its Carbamazepine extended-release tablets in the American market. The approval covers 100 mg, 200 mg, and 400 mg strengths.

The drug is prescribed for managing epilepsy and is also used to treat nerve pain associated with trigeminal neuralgia. Alembic’s version is a generic substitute for Tegretol-XR, a medicine originally developed by Novartis.

Citing IQVIA data, the company said the approved product addresses a US market worth an estimated $71 million for the twelve months ending March 2025.

With this development, Alembic’s total count of abbreviated new drug applications (ANDAs) approved by the USFDA has reached 225. This includes 202 final clearances and 23 tentative ones.

Alembic Pharmaceuticals shares closed at ₹999, which is a 1.91% dip on July 26, 2025. Alembic Pharmaceuticals shares dipped 17% in the last year, down 4.77% in the year-to-date, and gained 3.77% in the previous month.

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