Alembic Pharma gets tentative nod from USFDA for Febuxostat
New Delhi : 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.
Alembic Pharmaceuticals said it has settled the case with Takeda and will launch its generic as per the terms of settlement.
The tablets, indicated for chronic management of hyperuricemia in patients of gout, had an estimated market size of USD 430 million for 12 months to December 2015.
The company has 48 ANDA approvals (43 final and 5 tentative from the USFDA.
Alembic stock was trading 0.57 per cent up at Rs 582.75 in the morning trade on BSE.