Alembic Pharmaceuticals gets USFDA nod for generic Carbamazepine tablets
on Monday said it has received final approval from the
US health regulator
for its generic version of
Carbamazepine extended-release tablets
indicated for treatment of seizures, and relieving nerve pain.
The approval by the US Food & Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) of Carbamazepine extended-release tablets of strengths 100 mg, 200 mg, and 400 mg, it said in a statement.
The approved ANDA is therapeutically equivalent to the reference listed drug product Tegretol-XR extended-release tablets in the same strengths, of Novartis Pharmaceuticals Corporation, it added.
Alembic said Carbamazepine extended-release tablets are indicated for use as an
anticonvulsant drug
and also for the treatment of the pain associated with true trigeminal neuralgia.
Citing IQVIA data for the 12 months ended March 2025, the company said Carbamazepine extended-release tablets of 100 mg, 200 mg, and 400 mg, have an estimated market size of USD 71 million.
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