STN: BL 125106
Proper Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
Manufacturer: GlaxoSmithKline Biologicals, License #1617
- Booster immunization against tetanus, diphtheria and pertussis as a single dose in individuals 10 years of age and older.
November 27, 2013 Approval Letter - Boostrix
To change the product labeling in accordance with the guidance issued on March 11, 2013.
February 13, 2013 Approval Letter - Boostrix
To include changes to the Full Prescribing Information to update the Postmarketing Experience section.
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.
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