Ranbaxy Laboratories Limited (Ranbaxy), announced that the company has received the first approval from the US Food and Drug Administration (FDA) to market the anti-infective Cefaclor tablets, chewable, in 125 mg, 187 mg, 250 mg and 375 mg strengths. The Office of Generic Drugs, US FDA, has determined the Ranbaxy formulations to be bioequivalent and, has the same therapeutic effect as the reference listed drug Ceclor liquid, 125 mg, 187 mg, 250 mg and 375 mg, respectively, of Eli Lilly and Company.

Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy, will market this product under the brand name Raniclor 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 per cent market share and tablets 73 per cent market share, both of which will be affected by this new dosage form that will add to the ease of administration for patients, and caregivers.

Cefaclor USP is indicated in the treatment of infections such as, Otitis media, lower respiratory tract infections, including pneumonia, pharyngitis and tonsillitis, urinary tract infections, and skin and skin structure infections, when caused by susceptible strains of the designated microorganisms. Ceclor is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Raniclor will be promoted through an alliance with Capellon Pharmaceuticals, which will be providing sales and marketing support, and the Ranbaxy branded products team. Raniclor is expected to be available through wholesalers and other distribution outlets to dispensing pharmacies throughout the US on a nationwide basis by the end of February 2004.

Commenting on the approval, Jeff Thomas, vice president, brand products division, RPI, said "Raniclor 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 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 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 US Healthcare System."