Ranbaxy Pharmaceuticals Inc (RPI), a wholly owned subsidiary of the Ranbaxy Laboratories Ltd, has announced that the company has received approval from the US Food and Drug Administration to market amoxicillin and clavulanate Potassium for oral suspension USP, 600 mg / 42.9 mg (base) / 5 mL.
The division of bioequivalence has determined the company's formulation to be bioequivalent and, therefore, therapeutically equivalent to augmentin ES-600 for oral suspension, 600 mg / 42.9 mg (base) / 5 mL of GSK.
Augmentin ES-600 for oral suspension has combined sales of $216 million with sales of 600 mg / 42.9 mg (base) / 5 mL totalling $136.9 million in the suspension market.
Amoxicillin and clavulanate potassium for oral suspension, 600 mg / 42.9 mg (base) / 5 mL is indicated for the treatment of paediatric patients with recurrent or persistent acute otitis media due to S. pneumonia, H influenza, or M catarrhal as characterized by the following risk factors: antibiotic exposure for acute otitis media within the preceding 3 months and either of the following - age less than 2 years or day care attendance.
"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 Ltd. 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 US 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. The product will be available in April 2007," according to Jim Meehan, vice president of sales and marketing for RPI.