Ranbaxy Laboratories Limited has received approval from the US Food and Drug Administration to manufacture and commercialize Ofloxacin Tablets 200 mg, 300 mg, and 400 mg. The Office of Generic Drugs, US Food and Drug Administration, has determined Ranbaxy ' s Ofloxacin Tablets, 200 mg, 300 mg, and 400 mg, to be bioequivalent and, therefore, therapeutically equivalent to the listed drug (Floxin Tablets, 200 mg, 300 mg, and 400 mg, respectively, of Ortho McNeil Pharmaceutical Inc) In 2002, sales for Ofloxacin Tablets totaled $29.8 million (IMS - MAT, June 2003).

Ofloxacin Tablets (Floxin) are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible strains of the designated micro-organisms in the infections such as acute bacterial exacerbations of chronic bronchitis, community-acquired Pneumonia, uncomplicated skin and skin structure infections, acute, uncomplicated urethral and cervical gonorrhea, nongonococcal urethritis and cervicitis, mixed infections of the urethra and cervix, acute pelvic inflammatory disease, uncomplicated cystitis, complicated urinary tract infection, and Prostatitis.

Ofloxacin will be launched in the US market in September 2003 and will made available through wholesalers and other distribution outlets to dispensing pharmacies. The product will be marketed as a generic alternative to the branded product by the Sales Team of Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy.

According to Dipak Chattaraj, President of RPI, "The approval of Ofloxacin Tablets is yet another addition to the RPI product portfolio of anti-infectives. This product, with a well-established record of efficacy and safety in a variety of clinical indications, should find a niche position in a number of market segments, including managed care, private health plans, and governmental programs. We are delighted to offer this product as an affordable generic formulation to the branded product."

Chattaraj also remarked, "It is a formulation that has been developed through the talents and skills within Ranbaxy and represents a formulation that reflects our capabilities of producing product from the Active Pharmaceutical Ingredient (API) through the final packaged dosage form that will be sold under the RPI label, which serves to differentiate RPI from other generic pharmaceutical manufacturers."