Ranbaxy gets nod to market antibiotic in U.S.

Thursday, 14 August 2003, 19:30 IST
Printer Print Email Email
NEW DELHI: India's pharmaceutical major Ranbaxy Laboratories Ltd (RLL) has got approval from the U.S. to market a generic form of amoxicillin antibiotic tablets there. Ranbaxy is planning to launch its generic drug DisperMox in the U.S. by October, the company said in a statement Thursday. It has received permission for the move from the U.S. Food and Drug Administration. The drug in dosages of 200 mg and 400 mg tablets will be manufactured, marketed and distributed by Ranbaxy Pharmaceuticals Inc (RPI), a wholly owned subsidiary of RLL. Sales will be handled by Blansett Pharmacal Co. (Blansett), an Arkansas-based specialty pharmaceutical company engaged in developing and commercialising prescription drug products. Commenting on the approval, Dipak Chattaraj, president and CEO of RPI, said: "The combined efforts of both organisations represent a strategic alliance that is mutually beneficial and will serve to establish Ranbaxy's brand marketing efforts in future." This new dosage form of amoxicillin is recommended for paediatric patients with bacterial infections including Acute Otitis Media (AOM), sinusitis and tonsillopharyngitis, the company stated. AOM is the most common cause of frequent bacterial infection in children in the U.S. "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," the company stated. DisperMox will be competing in the antibiotic segment with a focus on the amoxicillin suspensions/chewable tablet market that is estimated to be in excess of $105.7 million in the U.S. With operations in over 70 countries, Ranbaxy's continued focus on research and development has resulted in its getting several approvals in developed markets and charting significant progress in new drug discovery research.
Source: IANS
siliconindia