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  1. Alembic Pharma gets tentative nod from USFDA for Febuxostat

Alembic Pharma gets tentative nod from USFDA for Febuxostat

Alembic Pharmaceuticals has received tentative approval from the US health regulator for Febuxostat tablets used for treatment of hyperuricemia in patients of gout.

By: | New Delhi | Updated: July 5, 2016 1:02 PM
Alembic Pharmaceuticals said it has settled the case with Takeda and will launch its generic as per the terms of settlement. (Reuters) Alembic Pharmaceuticals said it has settled the case with Takeda and will launch its generic as per the terms of settlement. (Reuters)

Alembic Pharmaceuticals has received tentative approval from the US health regulator for Febuxostat tablets used for treatment of hyperuricemia in patients of gout.

“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,” Alembic Pharmaceuticals said in a BSE filing.

The product is therapeutic equivalent to the reference listed drug Uloric tablets, 40 mg, 80 mg of Takeda Pharmaceuticals USA Inc, it added.

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