The Division of Bioequivalence has determined the Ranbaxy formulation to be bioequivalent and, therefore, therapeutically equivalent to Augmentin ES-600, which was developed by GlaxoSmithKline.
Amoxicillin and clavulanate potassium is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae, H. influenzae, or M. catarrhalis. Otitis media is an inflammation of the middle ear segment of the ear.
“This again demonstrates our depth and breadth of expertise and adds to our ever-expanding product portfolio, complimenting our commitment to bring affordable generic alternatives to the US healthcare system. This product will be available in April 2007,” said Jim Meehan, vice president of Sales and Marketing for Ranbaxy Pharmaceuticals.