Ranbaxy gets FDA nod for anti-infective

Ranbaxy Laboratories announced yesterday 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 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.

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.

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 designated microorganisms.

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.