Drug company Alembic Pharmaceuticals on Thursday said it has got approval from the US health regulator for its generic Nitrofurantoin capsules indicated for the treatment of urinary tract infections.
The firm has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for
Nitrofurantoin capsules, USP in the strengths of 25 mg, 50 mg and 100 mg, Alembic Pharma said in a regulatory filing.
The product is a generic version of Alvogen Malta Operations Ltd's Macrodantin capsules in the same strengths, it added.
As per IQVIA, Nitrofurantoin capsules, USP (Macrocrystals), 25 mg, 50 mg and 100 mg have an estimated market size of USD 23 million for the twelve months ending March 2021, Alembic Pharma said.
Nitrofurantoin capsules, is specifically indicated for the treatment of urinary tract infections when because of susceptible strains of escherichia coli, enterococci, staphylococcus aureus, and certain susceptible strains of klebsiella and enterobacter species, it added.
The company has a cumulative total of 146 abbreviated novel drug application (ANDA) approvals (128 final approvals and 18 tentative approvals) from USFDA, the filing said.
