Product Information

• Package Insert - ACAM2000 (PDF - 285KB)
  September 2009
• Medication Guide - ACAM2000 (PDF - 83KB)
  October 2009

Supporting Documents

• May 5, 2010 Approval Letter - ACAM2000
  Revisions: Change in the package insert, carton, vial, container and medication guide labeling for administrative changes and/or correction of inadvertent errors.
• August 31, 2007 Approval Letter - ACAM2000
  Active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.

Related Information

• FDA Approves Second-Generation Smallpox Vaccine
  Press Release: September 1, 2007
• ACAM2000 (Smallpox Vaccine) Questions and Answers
• FDA Online Label Repository
  Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.

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