Products
As of February 1, 2012, the chart below summarizes the status of our marketed products and compounds under development.
| * | ZEGERID is a non-promoted prescription product that continues to generate revenue. In addition, ZEGERID OTC® is promoted by Schering-Plough Healthcare Products, a subsidiary of Merck & Co., Inc. GlaxoSmithKline and Norgine have rights to ZEGERID in certain territories outside the U.S. |
| Full Prescribing and Safety Information | |
| Full prescribing and safety information for GLUMETZA, including a Black Box warning, is available at www.Glumetzaxr.com. Full prescribing and safety information for CYCLOSET is available at www.Cycloset.com. For Full prescribing and safety information for ZEGERID click here. |
- Phase I clinical trials: The product is tested in a small number of patients or healthy volunteers, primarily for safety at one or more doses.
- Phase II clinical trials: In addition to safety, the sponsor evaluates the efficacy of the products on targeted indications, and identifies possible adverse effects and safety risks, in a patient population somewhat larger than Phase I clinical trials.
- Phase III clinical trials: These trials typically involve additional clinical evaluations of safety and clinical efficacy in an expanded population at geographically-dispersed test sites.
- NDA (New Drug Application) or BLA (Biologics License Application) is submitted to FDA or foreign regulatory authority for review and approval.
- Marketed therapies are available in countries that have granted regulatory clearance.
For more detailed product information, please visit www.cycloset.com
For more detailed product information, please visit www.glumetzaxr.com
