RANBAXY WINS APPROVAL FOR GENERIC AUGMENTIN

Ranbaxy Pharmaceuticals has received approval from the FDA to market generic amoxicillin and clavulanate potassium for oral suspension. The FDA has determined the Ranbaxy formulation to be bioequivalent and, therefore, therapeutically equivalent to GlaxoSmithKline's Augmentin.

Augmentin 600 mg/42.9 mg/5 mL had total annual sales of $136.9 million for the year ending in September 2006, according to IMS Health.

The drug is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae, H. influenzae or M. catarrhalis characterized by the following risk factors: antibiotic exposure for acute otitis media within the preceding three months and either less than 2 years old or attending daycare.

The product will be available starting in April.