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Expanded Access, Compassionate Use, and Treatment IND Programs
January 2008

Drugs prescribed in the United States must be approved by the Food and Drug Administration (FDA). Some drugs, even before they are approved, may have benefits that outweigh the risks for diseases that have no approved treatment, or for people for whom approved treatments no longer work. Under such circumstances and with the approval of the FDA, pharmaceutical companies may create programs that allow patients limited access to promising drugs. These access mechanisms include expanded access, compassionate use, and treatment IND programs, and are created in the later stages of a drug's development.

Name of DrugClass of DrugCompanyProgram Contact and Information
TMC125 Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI) Tibotec TMC 125 Expanded Access Program
The expanded access program is currently available in these countries: Austria, Australia, Belgium, Canada, Denmark, Finland, France, Germany, Israel, Italy, Luxembourg, The Netherlands, Norway, Portugal, Spain, Sweden and Switzerland.
TMC114 Protease Inhibitor Tibotec TMC 114 Expanded Access Program
The expanded access program is currently available in these countries: Canada, Czech Republic, El Salvador, Estonia, Guatemala, Hong Kong, Hungary, Israel, Jamaica, Lithuania, Malaysia, Mexico, New Zealand, Panama, Portugal, Russia, Serbia, Singapore, Taiwan, Thailand, Turkey and Venezuela.