USFDA approves Alembic Pharma anticonvulsant drug Carbamazepine
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-04-18 07:17 GMT | Update On 2025-04-18 07:17 GMT
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Vadodara: Alembic Pharmaceuticals Limited announced that the US Food & Drug Administration (USFDA) has approved its Abbreviated New Drug Application (ANDA) for Carbamazepine Tablets USP, 200 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tegretol Tablets, 200 mg, of Novartis Pharmaceuticals Corporation. Carbamazepine Tablets USP, 200 mg are indicated for use as an anticonvulsant drug. It is also indicated in the treatment of the pain associated with true trigeminal neuralgia.
True Trigeminal Neuralgia (also known as Classical Trigeminal Neuralgia) is a chronic pain condition that affects the trigeminal nerve, which carries sensation from the face to the brain. It's characterized by sudden, severe, electric shock-like facial pain that typically affects one side of the face.
Carbamazepine Tablets USP, 200 mg have an estimated market size of US$ 32 million for twelve months ending December 2024 according to IQVIA.
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