Alembic Pharma gets USFDA nod for generic version of Uloric tablets
The approved product, Febuxostat tablet is therapeutically equivalent to the reference listed drug Uloric tablets of Takeda Pharmaceuticals USA, Inc.
New Delhi: Drug firm Alembic Pharmaceuticals Tuesday said it has received approval from the US health regulator for Febuxostat tablets, used to lower high levels of uric acid in adults who have gout.
The approved product is therapeutically equivalent to the reference listed drug Uloric tablets of Takeda Pharmaceuticals USA, Inc.
The company has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Febuxostat tablets in the strengths of 40 mg and 80 mg, Alembic Pharmaceuticals said in a filing to BSE.
Quoting IQVIA data, Alembic Pharma said Febuxostat tablets have an estimated market size of USD 578 million for twelve months ending December 2018.
The company currently has a total of 98 ANDA approvals (87 final approvals and 11 tentative approvals) from USFDA, it added.
Alembic had earlier received tentative approval for this ANDA from the US health regulator.