Alembic Pharma gets USFDA approval for urinary tract infection drug

Drug firm Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator for its generic Nitrofurantoin capsules indicated for the treatment of urinary tract infections. The company 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. According to IQVIA, Nitrofurantoin capsules, USP (Macrocrystals), 25 mg, 50 mg and 100 mg have an estimated market size of $23 million for the twelve months ending March 2021, Alembic Pharma said.