Alembic Pharma gets USFDA nod for anticonvulsant drug Carbamazepine Extended Release
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-07-26 07:31 GMT | Update On 2025-07-26 07:31 GMT
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Vadodara: An Indian multinational pharmaceutical company, Alembic Pharmaceuticals Limited, today announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tegretol-XR Extended Release Tablets, 100 mg, 200 mg, and 400 mg, of Novartis Pharmaceuticals Corporation.
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.
Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg, have an estimated market size of US$ 71 million for twelve months ending March 2025 according to IQVIA.
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