Ranbaxy Receives FDA Approval To Market A Generic Alternative To Macrobid(reg)

Main Category: Urology / Nephrology
Article Date: 03 Apr 2005 - 1:00 PDT

email to a friend   printer friendly   view / write opinions

Ranbaxy Laboratories Limited (RLL) announced today that the Company 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 formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Macrobid(reg). Total annual market sales for Nitrofurantoin Monohydrate/Macrocrystals Capsules were $80.0 million (IMS - MAT: December 2004).

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 ever 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, USA.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, manufactures and markets brand and generic pharmaceuticals and Active Pharmaceutical Ingredients. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. Ranbaxy's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies" resulting in a number of products under development. The Company is selling its products in over 100 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 44 countries and manufacturing operations in 7 countries.

*Macrobid(reg) is a registered trademark of Proctor and Gamble Pharmaceuticals, Inc.

ranbaxy.com/newsroom/pressrelease_det.asp?sno=204