Ranbaxy Laboratories Limited (RLL) has received final approval from the US Food and Drug Administration to market Metformin Hydrochloride Extended-release Tablets, 500 mg.

The Office of Generic Drugs, US Food and Drug Administration, has determined the Ranbaxy formulation to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Glucophage XR Tablets of Bristol Myers Squibb Company. Total market sales for the Metformin Extended-release formulation is $363 million (IMS - MAT: March 2004).

The approval was granted after Barr Laboratories Inc, a wholly-owned subsidiary of Barr Pharmaceuticals Inc selectively waived its rights to their exclusivity in favour of Ranbaxy, stated a company press release.

Metformin Hydrochloride Extended-release Tablets (Glucophage XR) as monotherapy, is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Glucophage is indicated in patients 10 years of age and older, and Glucophage XR is indicated in patients 17 years of age and older.

"This approval granted to RPI will be beneficial to diabetes patients and prescribers in providing an affordable generic alternative to the brand. The shipment of the product within USA has begun," said Jim Meehan, vice president, Sales and Marketing, RPI, USA.

RPI based in Jacksonville, Florida, is the wholly owned subsidiary of Ranbaxy Laboratories Limited, India. RPI is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.