Andrx Corporation announced that the US FDA has granted final marketing approval of Andrx's New Drug Application (NDA) for Fortamet (metformin HCl) Extended-Release tablets, 500 mg and 1000 mg. This NDA provides for the use of Fortamet as an adjunct to diet and exercise in order to lower blood glucose in patients with type 2 diabetes. Andrx is planning to launch Fortamet in May 2004.
Thomas P. Rice, Andrx's chief executive officer, said: "Our 500 mg and 1000 mg strengths of once-a-day Fortamet offer improved convenience and a reduction of pill burden for patients. Our 500 mg tablet is smaller than other currently available metformin tablets, and our 1000 mg tablet is a unique strength that will allow patients to more easily manage their optimal daily dosage requirements. These two strengths of Fortamet are intended to improve patient compliance and further demonstrate the value of Andrx's controlled-release technologies."
Fortamet extended-release tablets employ Andrx's patented single-composition osmotic technology. Fortamet is an extended-release metformin that suppresses hepatic glucose production and improves peripheral insulin sensitivity.