Sciele Pharma said the FDA has approved all four dosage strengths of the new Sular formulation, which utilizes SkyePharma's patented Geomatrix technology and provides a lower dose of Sular for each of its current doses. Sciele expects to launch the new Sular formulation during the first quarter of 2008.
Depomed said the FDA has approved 1000 mg strength tablets of Glumetza for patients with type 2 diabetes.
Drug developer Watson Pharmaceuticals said the FDA approved its generic version of Dey's respiratory condition treatment DuoNeb. The drug treats breathing difficulty in patients with chronic obstructive pulmonary disease. Watson plans to start selling the generic drug immediately.
Cell Therapeutics Inc. (CTI) announced that it has completed its acquisition of Zevalin (ibritumomab tiuxetan) from Biogen Idec, giving CTI sole responsibility for marketing, sales, and development of the drug in the US. Zevalin will continue to be sold outside the US by Bayer Schering under an agreement between Biogen Idec and Bayer Schering. Approved in 2002 to treat patients with relapsed indolent non-Hodgkin's lymphoma, Zevalin was the first radioimmunotherapy to be approved by the FDA. In 2006, Biogen Idec reported $16.4 million in US Zevalin sales.