The FDA gave its blessing to more than a dozen generic versions of GlaxoSmithKline's Coreg (aka carvedilol), used to treat a variety of cardiovascular problems including high blood pressure and heart failure. Now, Glaxo will have to share the $1.7 billion carvedilol market with the likes of Actavis, Apotex, Caraco, Dr. Reddy's, Ranbaxy, Sandoz, Teva, and Watson, among others. A total of 14 generics were approved.
Ironically, the generic labeling may differ from the brand-name version because, while the drug itself is no longer under patent, certain bits of the labeling are.Â
- see the FDA release [1]
Related Articles:
Riled investors look for big changes at GSK. Report [2]
Patent 'cliff' looms for Big Pharma. Report [3]
Links:
[1] http://www.fiercebiotech.com/press-releases/press-release-fda-approves-first-generic-versions-coreg
[2] http://www.fiercepharma.com/story/riled-investors-look-big-changes-gsk/2007-09-04
[3] http://www.fiercebiotech.com/story/patent-cliff-looms-for-big-pharma/2007-05-02?utm_medium=rss&utm_source=rss