New Delhi: Drug firm Lupin said it has received final approval from the US health regulator to market its antibacterial Nitrofurantoin capsules used for treating urinary tract infections.
The approval from the United States Food and Drug Administration (USFDA) is to market the Nitrofurantoin capsules in the strengths of 50 mg and 100 mg, Lupin said in a statement.
The product is a generic version of Alvogen Malta Operations Ltd’s Macrodantin capsules in the same strengths, it added.
The capsules are indicated for the treatment of urinary tract infections caused by certain bacteria, Lupin said.
As per the IQVIA MAT April 2018 data Nitrofurantoin capsules USP 50 mg and 100 mg had annual sales of around USD 27 million in the US, it added.