STN: BL 125158
Proper Name: Smallpox (Vaccinia) Vaccine, Live
Manufacturer: Sanofi Pasteur Biologics LLC, License No. 1815
- Active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.
February 5, 2016 Approval Letter - ACAM2000(PDF - 41KB)
To change the package insert to include clarifying revisions to Section 5 and to reflect the removal of the requirement to have a risk evaluation and mitigation strategy (REMS)
- August 24, 2015 Risk Evaluation and Mitigation Strategy Release Letter - ACAM2000 (PDF - 35KB)
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.
FDA Approves Second-Generation Smallpox Vaccine[ARCHIVED]
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.