Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Teriflunomide Tablets, 7 mg and 14 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Aubagio Tablets, 7 mg and 14 mg, of Sanofi-Aventis US, LLC (Sanofi-Aventis). Teriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis. Teriflunomide Tablets, 7 mg and 14 mg have an estimated market size of $1.6 billion for twelve months ending December 2018 according to IQVIA.
The company has settled the litigation and will launch the product as per the terms of the settlement. Alembic now has a total of 91 ANDA approvals (79 final approvals and 12 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
