The office of generic drugs, USFDA, determined the Ranbaxy formulations to be bioequivalent and having the same therapeutic effect as of Macrobid, a registered trademark of Proctor and Gamble Pharmaceuticals, Ranbaxy informed the Bombay Stock Exchange.
The total annual market sales for nitrofurantoin monohydrate/macrocrystals capsules is $80 million, it said.
"Our plans are to bring this product to the market as quickly as possible during the month of April," Ranbaxy Pharmaceuticals Inc vice-president, sales and marketing, Jim Meehan, said.
Nitrofurantoin monohydrate/macrocrystals capsules are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus, it said.