Ranbaxy gets USFDA nod for new drug

Ranbaxy Laboratories [ Get Quote ] on Friday said it had received approval from US Food and Drug Administration to manufacture and market nitrofurantoin monohydrate macrocrystals capsules (100 mg) and planned to bring the new drug to the market in April.

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 [ Images ].

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.