Tuesday, October 19, 2004

IN BRIEF: BARR LABORATORIES INC.

Barr Laboratories Inc. received Food and Drug Administration approval to market a generic brand version of Bristol-Myers Squibb Co.'s Glucophage XR (metformin hydrochloride extended-release) 750 mg tablets. The company said the FDA's approval letter awarded Barr 180 days of generic exclusivity for the product, which is indicated as an adjunct to diet and exercise to improve glycemic control in patients aged 17 years or older who have type 2 diabetes.

Tuesday, June 22, 2004

IN BRIEF: IMPAX LABORATORIES INC.

Impax Laboratories Inc. received a second-tier 180-day exclusivity period from the Food and Drug Administration related to its pending Abbreviated New Drug Application for 500 mg metformin hydrochloride extended-release tablets, a generic brand version of diabetes drug Glucophage XR. The pharmaceutical company selectively waived its rights to this exclusivity to Teva Pharmaceuticals USA Inc. and will share profits from Teva's generic version. Glucophage is a registered trademark of Merck Sante S.A.S., an associate of Merck KGaA, and is licensed to Bristol-Myers Squibb Co.