Alembic Pharmaceuticals Ltd has received tentative approval from the US Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) for febuxostat tablets – 40 mg and 80 mg. The approved product is generic equivalent of Takeda Pharmaceuticals USA Inc’s Uloric tablets, used for treating chronic management of hyperuricemia in patients with gout.
Alembic has settled the case with Takeda and will launch its generic as per the terms of the settlement.
Uloric has an estimated market size of $ 430 million for twelve months ending December 2015, according to IMS.
Alembic now has a total of 48 ANDA approvals (43 final approvals and 5 tentative approvals) from the US FDA.