FDA Approves Ranbaxy's Generic Macrobid

The FDA has approved Ranbaxy Laboratories' abbreviated new drug application for nitrofurantoin monohydrate/macrocrystals capsules in a 100-mg dose.

Ranbaxy's drug is the generic version of Procter & Gamble's Macrobid, which is indicated for the treatment of acute uncomplicated urinary tract infections caused by certain strains of escherichia coli or staphylococcus saprophyticus. Macrobid generated approximately $80 million in sales in 2004, according to IMS Health data.