Alembic Pharmaceuticals Secures USFDA Nod for Carbamazepine Tablets
Alembic Pharmaceuticals has received final approval from the USFDA for its generic Carbamazepine extended-release tablets, used for treating seizures and nerve pain. The approval covers 100 mg, 200 mg, and 400 mg tablets, and the market size for these generics is estimated at USD 71 million.
- Country:
- India
Alembic Pharmaceuticals announced on Monday that it has secured final approval from the US Food & Drug Administration for its generic version of Carbamazepine extended-release tablets. These tablets are crucial for those undergoing treatment for seizures and require relief from nerve pain.
The USFDA's nod pertains to Alembic's abbreviated new drug application for Carbamazepine tablets available in strengths of 100 mg, 200 mg, and 400 mg. According to the company, this therapeutic alternative is equivalent to the reference drug, Tegretol-XR, by Novartis Pharmaceuticals Corporation.
Alembic highlighted the application of these tablets as an effective anticonvulsant and for addressing trigeminal neuralgia pain. Citing IQVIA data, Alembic remarked on an estimated market valuation of USD 71 million for these drug strengths over the 12 months ending in March 2025.
(With inputs from agencies.)
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