Alembic Pharma gets US FDA nod for diabetes drug

Alembic Pharmaceuticals has received tentative approval from the US health regulator to market Alogliptin and Metformin Hydrochloride tablets, an anti-diabetes medication, in the US market.

The company’s product is a generic version of Takeda Pharma USA’s Kazano tablets, Alembic Pharmaceuticals said in a regulatory filing.

Alogliptin and Metformin Hydrochloride tablets had an estimated market size of $ 22.5 million in the US for 12 months ending December 2017, according to the market data.

Alembic now has a total of 77 abbreviated new drug application (ANDA) approvals from the US FDA.

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