Ranbaxy gets US nod to mkt its drug

NEW DELHI: Gurgaon-based pharmaceutical major Ranbaxy Labs today announced that RLL has received approval from the US Food and Drug Administration to market Amoxicillin and Clavulanate Potassium for Oral Suspension. The Division of Bioequivalence has determined the Ranbaxy formulation to be bioequivalent and, therefore, therapeutically equivalent to Augmentin ES-600 for Oral Suspension of GlaxoSmithKline.

"We are delighted to make yet another dosage form of Amoxicillin available based on the skills and talents that are available through our parent company, Ranbaxy Laboratories Limited. This again demonstrates our depth and breadth of expertise to add to our ever expanding product portfolio, along with our commitment to bring affordable generic alternatives to the U.S. healthcare system. We are adding yet another product that has clinical utility and value, and as such, will distinguish Ranbaxy in the years to come. Product will be available in April 2007,said Jim Meehan, VP(Sales and Marketing, RPI.

RPI is a wholly-owned subsidiary of Ranbaxy Labs.

Augmentin ES-600 for Oral Suspension has combined sales of $216 million with sales of 600 mg/42.9 mg (base) / 5 ml totaling $136.9 million in the suspension market, according to IMS ��� MAT: September 2006. Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg (base) / 5 ml is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media.