Ranbaxy Laboratories Limited (RLL) has received approval by the U.S. Food and Drug Administration (FDA) to market Cefadroxil Powder for Oral Suspension USP in 125 mg/5 ml, 250 mg/5 ml and 500 mg/5 ml strengths. The Division of Bioequivalence has determined Ranbaxy's Cefadroxil for Oral Suspension USP, 125 mg/5 ml, 250 mg/5 ml, and 500 mg/5 ml, to be bioequivalent and, therefore, therapeutically equivalent to the listed drug Duricef for Oral Suspension, 125 mg/ 5 mL, 250 mg/5 mL, and 500 mg/5 mL, respectively, of Warmer Chilcott Inc.
Duricef, a cephalosporin antibiotic, is used in the treatment of nose, throat, urinary tract infections, skin and skin structure infections, pharyngitis and/or tonsillitis that are caused by specific bacteria, including staph, strep, and E. coli. Patients who are allergic to either penicillin or cephalosporin antibiotics in any form should consult their doctor before taking Cefadroxil Powder for Oral Suspension. In 2002, the total sales of Cefadroxil totalled $37.7 Million, while sales of the suspensions were $16.7 Million (IMS - MAT, Dec. 2002).
The product is expected to be launched in June 2003 through wholesalers and other distribution outlets to dispensing pharmacies throughout the United States of America. Product will be featured in a variety of package sizes including 125 mg/ 5 mL in 100 mL, 250 mg/ 5 ml in 100 ml, and 500 mg ' / 5 ml in 75 ml and 100 ml bottles.
Commenting on the approval, Dipak Chattaraj, President, Ranbaxy Pharmaceuticals Inc (RPI), USA said, " This product will further expand the Ranbaxy product portfolio of anti-infective agents that includes cephalosporin and semi-synthetic penicillins to provide clinicians and patients with alternative, affordable medicines. In the future, products will be added to grow the anti-infective category and provide greater breadth and depth of products to provide prescribers with flexibility in meeting the clinical needs of patients."
He further added, " This product is representative of a fully integrated pharmaceutical company that produces products from Active Pharmaceutical Ingredients (API) to the manufacture and ultimate marketing of the dosage forms that will be sold exclusively under the RPI label. This capability provided by our parent company RLL is a point of distinction for RPI in the U.S. generic pharmaceutical marketplace. "