Lupin has received the nod from the Food and Drug Administration for the generic version of Alvogen Malta Operation’s Macrodantin capsules (nitrofurantoin capsules - macrocrystals) in 50-mg and 100-mg dosage strengths.
The product is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.
The product’s market size for the 12 months ended April 2018 was approximately $27 million, according to IQVIA data.