Ranbaxy Laboratories has been granted approval by the US Food and Drug Administration (FDA) to market an amoxycillin and clavulanate potassium combination (oral suspension).
The Division of Bioequivalence has determined Ranbaxy formulations to be therapeutically equivalent to Augmentin of GlaxoSmithKline.
Augmentin has combined sales of $1.2 billion, with the suspension market alone comprising $272.5 million of sales.
Sales and marketing for this product would be supported by the Ranbaxy sales and marketing group.
The product will be made available to all dispensing outlets located throughout the US including chain pharmacies, wholesalers, and generic distributors as soon as inventories are achieved to support market requirements, a company statement said.
Commenting on the approval, Dipak Chattaraj, president and chief executive officer of Ranbaxy Pharmaceuticals Inc, US, said,
