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The US health regulator has provided its tentative approval to Alembic Pharmaceuticals for Febuxostat tablets that are used in the treatment of hyperuricemia in patients of gout.
Alembic Pharmaceuticals has said in a BSE filing that “The company has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Febuxostat tablets, 40 mg and 80 mg.”
It further said that the product is therapeutic equivalent to the reference listed drug Uloric tablets, 40 mg, 80 mg of Takeda Pharmaceuticals USA Inc.
