Alembic receives US FDA approval for gout drug febuxostat

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-Pharmaceuticals

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.

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