Alembic Pharmaceuticals has received nod from US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Febuxostat Tablets, 40 mg and 80 mg. The approved ANDA is therapeutically equivalent to the: reference listed drug (RLD), Uloric Tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals U.S.A., Inc. (Takeda). Febuxostat Tablets has an estimated market size of $578 million for twelve months ending December 2018.
The company had previously received tentative approval for this ANDA. But now company has a total of 98 ANDA approvals (87 final approvals and 11 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
