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As of January 2010, the chart below summarizes the status of our marketed products and products under development.
| * | Schering-Plough's NDA approved December 1, 2009 (Schering-Plough HealthCare Products, Inc. is a division of Merck & Co., Inc.) |
| ** | NDA approved December 4, 2009 |
| *** | GSK currently promotes ZegeridŽ Rx products in Puerto Rico and USVI. Regulatory submissions made in Latin America and Africa |
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) is submitted to FDA or foreign regulatory authority for review and approval.
Marketed therapies are available in countries that have granted regulatory clearance.
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