Ranbaxy Laboratories, in a release issued to the BSE on Thursday, said the US Food and Drug Administration has granted the company permission to market DisperMox (amoxicillin tablets for oral suspension - 200mg and 400mg).
"The office of generic drugs (OGD) has ruled that the Ranbaxy formulation can be expected to have the same therapeutic effect as that of the reference listed drug upon which the agency relied as the basis of safety and effectiveness," the release said.
The drug will be competing in the antibiotic segment with a focus on the amoxicillin suspensions/chewable tablet market estimated to be around $106 million in the United States.
The new dosage form of amoxicillin, the release said, will be beneficial for pediatric patients with bacterial infections including acute otitis media.
DisperMoxTM will be launched in the US by October 2003, and will be marketed and distributed by Ranbaxy Pharmaceuticals Inc, a wholly-owned subsidiary of Ranbaxy, the release said.