PRINCETON, N.J., Dec. 23 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received the first approval from the U.S. Food and Drug Administration to market the anti-infective Cefaclor Tablets, Chewable in 125 mg, 187 mg, 250 mg and 375 mg strengths. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and, has the same therapeutic effect as the reference listed drug Ceclor(R) Liquid, 125 mg, 187 mg, 250 mg and 375 mg, respectively, of Eli Lilly and Company.
RPI will be responsible for marketing this product under the brand name Raniclor(TM) in this newly formulated dosage form that will add prescribing flexibility to this clinically useful product. Annual Cefaclor sales are $21.3 million (IMS - MAT, September 2003). Liquid holds 27% market share and tablets 73% market share, both of which will be affected by this new dosage form that will add to the ease of administration for patients, and in many cases, caregivers.
Cefaclor, USP is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Otitis media, lower respiratory tract infections, including pneumonia, pharyngitis and tonsillitis, urinary tract infections, and skin and skin structure infections. Ceclor(R) is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Raniclor(TM) will be promoted through an alliance with Capellon Pharmaceuticals, Fort Worth, TX, which will be providing sales and marketing support, and the Ranbaxy branded products team, which has the specific mission of launching brand name products that will materialize through the Ranbaxy pipeline in the years to come. Raniclor(TM) is expected to be available through wholesalers and other distribution outlets to dispensing pharmacies throughout the United States on a nationwide basis by the end of February 2004.
According to Jeff Thomas, Vice President of Brand Products Division of Ranbaxy Pharmaceuticals Inc., "Raniclor(TM) represents yet another significant milestone for Ranbaxy, as we have gained FDA approval for a product that was developed and will be manufactured completely within the Ranbaxy organization. As a novel dosage form, Raniclor(TM) fulfills the need of patients who cannot ingest Cefaclor capsules, while at the same time eliminating the need for refrigeration and improving portability, compared to the liquid suspension of Cefaclor. Both practically and clinically useful, we believe Raniclor(TM) chewable tablets will assume a niche position in the anti-infective market."
According to David Brown, President of Capellon Pharmaceuticals, "This is a unique opportunity for Capellon to promote a product with clinical value to our primary care physician audience that is the focus of our historical and future commercial efforts. We welcome the strategic alliance with RPI surrounding this product, which we see as being mutually beneficial between both companies and the U.S. Healthcare System."
ABOUT RANBAXY PHARMACEUTICALS INC.
Based in Princeton, New Jersey, RPI is a wholly owned subsidiary of RLL, India having established operations in the U.S. in 1994, and launching its first prescription product in January 1998, following FDA approval in August 1997. For the year 2002, U.S. operations achieved sales of U.S. $296 Mn, a growth of 162% over the corresponding year. During 2002, RPI filed 23 ANDAs (surpassing its target of 15-20 ANDA filings annually) and received 11 approvals. RPI markets a basket of generic products covering major therapeutic areas. In 2002, RPI was ranked as the 9th largest company in the U.S. generics market.
Raniclor(TM) is a pending trademark of Ranbaxy Laboratories Limited
Ceclor (R) is a registered trademark of Eli Lilly and Company
Ranbaxy Pharmaceuticals Inc.