Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Febuxostat Tablets, 40 mg and 80 mg. Febuxostat Tablets are indicated for the chronic management of hyperuricemia in patients with gout.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Uloric Tablets, 40 mg and 80 mg of Takeda Pharmaceuticals USA, Inc. According to IMS, Uloric had an estimated market size of $430 million for twelve months ending December 2015.
Besides, Alembic has settled the case with Takeda and will launch its generic as per the terms of the settlement. The pharma major now has a total of 48 ANDA approvals (43 Final approvals and 5 tentative approvals) from USFDA.
