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FDA Approves Generic Alternative to Macrobid

PRINCETON, N.J., April 1 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received approval from the U.S. Food and Drug Administration to manufacture and market Nitrofurantoin Monohydrate/Macrocrystals Capsules, 100 mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulation to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Macrobid.

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.

"We are delighted to receive approval from the U.S. FDA to market this product to add to our every growing generic product portfolio. Our plans are to bring this product to the market as quickly as possible during the month of April," according to Jim Meehan, Vice President of Sales and Marketing for RPI.

Source: Ranbaxy Pharmaceuticals, Inc.

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