Ranbaxy Laboratories Limited (RLL) has received approval by the U.S. Food and Drug Administration to market Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg (base)/5 mL and 400 mg/57 mg (base)/5 mL. The Division of Bioequivalence has determined the Ranbaxy formulations to be bioequivalent and, therefore, therapeutically equivalent to Augmentin for Oral Suspension, 200 mg/5 mL, and 400 mg/5 mL, respectively, of GlaxoSmithKline. Augmentin has combined sales of $1.2 billion with total sales of $272.5 million in the suspension market (IMS - MAT: December 2002).
Amoxicillin and Clavulanate Potassium for Oral Suspension is indicated for the treatment of infections caused by susceptible strains of the designated organisms in the conditions like Lower Respiratory Tract Infections, Otitis Media, Sinusitis, Skin and Skin Structure Infections, and Urinary Tract Infections. While Augmentin is indicated only for these conditions listed above, infections caused by Ampicillin-susceptible organisms are also amenable to Augmentin treatment due to its Amoxicillin content.
Commenting on the approval, Dipak Chattaraj, President and CEO of Ranbaxy Pharmaceuticals Inc., USA, said. "We were 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 expanding product portfolio, along with our commitment to bring 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".
Sales and marketing for this product will be supported by the Ranbaxy Sales and Marketing Group and product will be made available to all dispensing outlets located throughout the U.S. including chain pharmacies, wholesalers, and generic distributors as soon as inventories are achieved to support market requirements.