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HomeMarket NewsAlembic Pharma gets USFDA nod for anti-convulsant drug Carbamazepine
The Carbamazepine extended-release tablets are indicated for use as an anti-convulsant drug and also for the treatment of the pain associated with true trigerminal neuralgia, Alembic Pharma said.
Alembic Pharmaceuticals Ltd. on Saturday, July 26, said it has received final approval from the US Food and Drug Administration (USFDA) for the Carbamazepine extended release tablets USP in the 100mg, 200mg and 400 mg strengths.
The approved abbreviated new drug application (ANDA) is thereapuetically equivalent to the reference listed drug product Tegretol-XR ExtendedRelease Tablets, 100 mg, 200 mg, and 400 mg, of Novartis Pharmaceuticals Corporation, the company said.
The Carbamazepine extended-release tablets are indicated for use as an anti-convulsant drug and also for the treatment of the pain associated with true trigerminal neuralgia, Alembic Pharma said.
As per IQVIA, the tablets have an estimated market size of $71 million for the 1w months ending March 2025.
Alembic Pharma has a total of 225 ANDA approvals from the USFDA, including 202 final approvals and 23 tentative ones.
Alembic Pharma shares ended the previous session 1.91% lower at ₹999 apiece. The stock has declined 4.77% this year, so far.
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