Alembic Pharmaceuticals gains USFDA final approval for Carbamazepine Extended-Release Tablets
Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug and also for treating pain associated with true trigeminal neuralgia
Alembic Pharmaceuticals announced that it 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 $ 71 million for the twelve months ending March 2025, according to IQVIA.
Alembic has a cumulative total of 225 ANDA approvals (202 final approvals and 23 tentative approvals) from the USFDA.