Ranbaxy Laboratories Limited (RLL) has received approval from the US Food and Drug Administration to market DisperMox (Amoxicillin Tablets for Oral Suspension, 200 mg and 400 mg). This new dosage form of Amoxicillin will be especially beneficial for pediatric patients with bacterial infections including Acute Otitis Media (AOM).
The Office of Generic Drugs (OGD) has determined that the Ranbaxy formulation can be expected to have the same therapeutic effect as that of the reference listed drug product, upon which the agency relied as the basis of safety and effectiveness. It will be competing in the antibiotic segment with a focus on the Amoxicillin suspensions/chewable tablet market estimated to be in excess of $105.7 Mil (IMS: April 2003) in the US.
DisperMox embodies a new dosage form of Amoxicillin designed to build on the strong efficacy, safety, and tolerability features of Amoxil (Amoxicillin chewable tablets and powder for oral suspension) and provide additional benefits in terms of dosing accuracy and is available as a pleasant strawberry flavor. The product is administered as a convenient, twice-a-day dosage regimen. Since DisperMox is a tablet, not requiring refrigeration, it can be taken anywhere.
DisperMox will be launched in USA by October 2003 and will be marketed and distributed by Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of RLL through wholesalers, distributors and pharmacies. Market development of this novel dosage form and manufacturing will remain a primary role of Ranbaxy, whereas the sales activities will be driven by Blansett Pharmacal Co. (Blansett), Arkansas, a specialty pharmaceutical company, engaged in developing and commercializing prescription drug products. The sales force to support the promotion of DisperMox will total 150 sales representatives by September 2003.
Commenting on the approval, Dipak Chattaraj, President and CEO of RPI, said, "The combined efforts of both organizations represent a strategic alliance that is mutually beneficial and will serve to establish Ranbaxy's brand marketing efforts in the future. More importantly, DisperMox will play a key role in the treatment of patients with AOM and other pediatric infections, including sinusitis and tonsillopharyngitis. It represents a new and improved way of taking a well-defined and dependable product."
AOM is the most common cause of pediatric office visits (exceeding 35 million in 2001) in the United States and represents the most frequent bacterial infection in children. It represents a considerable burden to the U.S. healthcare system, incurring an annual cost of over $5 Billion.