Alembic Pharma Gets Tentative Approval For Febuxostat From U.S. FDA
Alembic Pharmaceuticals Ltd. has received tentative approval from the U.S. health regulator for Febuxostat tablets, the company said in a press release.
Febuxostat is used to treat gout deal with excess uric acid in the body.
The company has received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Febuxostat tablets, 40 mg and 80 mg.Alembic Pharmaceuticals Press Release
The tablet has an estimated market size of $430 million for 12 months to December 2015.
Alembic Pharma also said that it had settled a case with Takeda and will launch its generic according to the terms of that settlement.
The company has a total of 48 ANDAs from the U.S. FDA of which 43 have final approvals while rest have tentative ones.
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