Product Approval Information

Proper Name: Smallpox (Vaccinia) Vaccine, Live
Tradename: ACAM2000
Manufacturer: Acambis Inc., License No. 1733

Package Insert (PDF - 397 KB) - August, 2007
Medication Guide (PDF - 230 KB) - August, 2007


Date: August 31, 2007
Indication: Active immunization against smallpox disease for persons determined to be at high risk for smallpox infection
August 31, 2007 Approval Letter
Questions and Answers: ACAM2000 Smallpox (Vaccinia) Vaccine
FDA Approves Second-Generation Smallpox Vaccine
FDA Approves New Smallpox Vaccine (Consumer Upddate)

 
Updated: September 5, 2007