Product Information

• Package Insert - Boostrix (PDF - 207KB)

Supporting Documents

• September 26, 2012 Approval Letter - Boostrix
  To include a change in the Pregnany Category designation in the package insert from Category C to Category B.
• September 10, 2012 Approval Letter - Boostrix
• March 12, 2012 Approval Letter- Boostrix
  To include changes to the package insert to include "syncope" to the Warnings and Precaution section in Highlights and the Full Prescribing Information.
• July 8, 2011 Summary Basis for Regulatory Action - Boostrix (PDF - 115KB)
• July 8, 2011 Approval Letter - Boostrix
  To include immunogenicity and safety data to support the use of Boostrix® in individuals 65 years of age and older.
• March 17, 2011 Approval Letter - Boostrix
  To revise package insert in the PLR format that includes clinical data describing the concomitant use of Boostrix® and Menactra®.
• December 1, 2010 Approval Letter - Boostrix
  To revise labeling to address latex hypersensitivity in the Warnings and Precautions.
• December 4, 2008 Approval Letter - Boostrix
  To include single booster dose in adults 19-64 years of age for active immunization against tetanus, diphtheria, and pertussis.
• December 29, 2005 Approval Letter - Boostrix
  To include addition of clinical safety information to the package insert.
• May 3, 2005 Approval Letter - Boostrix
  Booster immunization against tetanus, diphtheria and pertussis as a single dose in adolescents 10-18 years of age.

Related Information

• FDA Online Label Repository
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