Ranbaxy Laboratories Limited has received tentative approval from the US Food and Drug Administration to manufacture and market Levofloxacin Tablets, 250 mg, 500 mg, and 750 mg. Total market sales for Levofloxacin tablets were $1.27 billion with a growth rate of 18 per cent (IMS - MAT: June 2004).
Levofloxacin is indicated for the treatment of adults with mild, moderate and severe infections caused by susceptible strains of designated micro-organisms in the conditions- Acute maxillary sinusitis; Acute bacterial exacerbation of chronic bronchitis; Nosocomial pneumonia; Community-acquired pneumonia; Complicated skin and skin structure infections etc, a release from Ranbaxy says.
"We are delighted to receive this tentative approval for a product that has both utility and value in the management of patients suffering from bacterial infections. We will launch Levofloxacin tablets at the time the final product approval is received from the US FDA," according to Jim Meehan, vice president of sales and marketing for RPI.
Ranbaxy Pharmaceuticals Inc (RPI) based in Jacksonville, Florida, is the wholly owned subsidiary of Ranbaxy. RPI is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.