Ranbaxy gets USFDA approval for metformin tabs

EPP News Bureau - New Delhi

Ranbaxy Laboratories Limited (RLL) has announced that the company has received approval from the US Food and Drug Administration to manufacture and market metformin hydrochloride extended-release 750mg tablets.

The Office of Generic Drugs, US Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Glucophage XR Extended-release tablets, 750 mg, according to a press release. Total annual market sales for metformin XL tablets were $227 million (-49 percent) with market sales of metformin XL tablets 750mg of $29.0 million (+61 percent) (IMS-MAT: March 2005), the release added.

‘‘This is a wonderful opportunity for Ranbaxy to introduce another affordable generic alternative to the U.S. healthcare system. It also marks a major milestone as the 100th ANDA approval held by RLL allowing us to market another ethical product under the Ranbaxy label in the US,’’ said Jim Meehan, Vice-President of Sales and Marketing for Ranbaxy Pharmaceuticals Inc, USA.