Ranbaxy granted first USFDA approval for Ceflaclor tablets

EPP News Bureau - Mumbai

Ranbaxy Laboratories Limited (Ranbaxy), announced that the company has received the first approval from the US 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, US Food and Drug Administration, 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 in many cases, 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 infectins, when caused by susceptible strain 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, Fort Worth, TX, 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 United States 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 organisation.”