USFDA26 Jul 2025, 11:41 am
Alembic Pharmaceuticals Receives USFDA Final Approval for Carbamazepine Extended-Release Tablets
AI Summary
Alembic Pharmaceuticals Ltd has received US Food & Drug Administration (USFDA) Final Approval for 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. The approved product has an estimated market size of USD 71 million for twelve months ending March 2025 according to IQVIA.
Key Highlights
- Alembic Pharmaceuticals receives USFDA Final Approval for 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
- The approved product has an estimated market size of USD 71 million for twelve months ending March 2025 according to IQVIA
- Alembic Pharmaceuticals Ltd has a cumulative total of 225 ANDA approvals (202 final approvals and 23 tentative approvals) from USFDA