News
Ranbaxy Labs receives FDA nod to market amoxicillin & clavulanate
Ranbaxy Laboratories said Wednesday that its wholly owned subsidiary, Ranbaxy Pharmaceuticals (RPI), has received an approval from the US FDA to market amoxicillin and clavulanate potassium for oral suspension USP.
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 GlaxoSmithKline.
Augmentin ES-600 for oral suspension has combined sales of USD 216 million with sales of 600 mg / 42.9 mg (base) / 5 mL totaling USD 136.9 million in the suspension market.
"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. 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", the company official said.
The shares of company closed up Rs 6.15, or 1.53%, at Rs 408.60 at the BSE. The total volume of shares traded was 263,700 (Wednesday).