Corporate Statement on Animal Testing
The U.S. Food and Drug Administration (FDA) and other worldwide health regulatory agencies currently require all pharmaceutical and medical device manufacturers to protect patients and consumers by establishing product quality, safety and effectiveness through approved and validated testing methods, which may include animal testing.
When animal work is necessary it is designed to ensure the highest standards of animal welfare and undergoes ethical review, approval and oversight from an Institutional Animal Care and Use Committee (IACUC).
Allergan shares the pharmaceutical industry's goal of reducing or eliminating animal testing wherever possible and is committed to the "3Rs" principles of refinement, reduction and eventual replacement of laboratory animals in product testing. In this regard, Allergan has developed and gained regulatory approvals of a cell-based potency assay to replace an animal-based assay for use in the ongoing manufacturing of BOTOX®. Allergan uses only the cell-based potency assay when performing BOTOX® drug product release and stability testing.
For additional information or questions, please contact Allergan Customer Relations:
Phone: +1 800 678 1605