STN: BL 125111
Proper Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
Manufacturer: Sanofi Pasteur, Ltd, License #1726
- Booster immunization against tetanus, diphtheria and pertussis as a single dose in individuals 10 through 64 years of age
February 11, 2015 Approval Letter - Adacel
To include a statement to the Patient Information Sheet advising patients to inform their healthcare provider of any prior history of syncope.
March 24, 2014 Summary Basis for Regulatory Action - Adacel(PDF - 74KB) March 28, 2014 Approval Letter-Adacel
To lower the age indication for Adacel administration from 11 to 10 years of age.
July 23, 2013 Approval Letter - Adacel
To include revisions to the NDC, 2D barcode on the detachable portion of the label and a new logo.
May 29, 2013 Approval Letter - Adacel
To include the addition of an expiration date "(E)" on the detachable portion of the vial label.
April 16, 2013 Approval Letter - Adacel
To include detachable syringe labels designed with a 2D Barcode.
February 16, 2012 Approval Letter - Adacel
To include geriatric use language in the label consistent with the geriatric labeling requirements and revise the content and format of the label.
February 15, 2012 Clinical Review - Adacel(PDF - 310KB) January 30, 2012 Summary Basis for Regulatory Action - Adacel(PDF - 114KB) February 11, 2011 Approval Letter - Adacel
Added a Patient Prescribing Information (PPI) sheet to the labeling.
January 13, 2011 Approval Letter - Adacel
Revised Package Insert of Latex hypersensitivity
January 16, 2009 Approval Letter - Adacel
To revise the package insert to include revision of the placement of infonnalion regarding latex content of the product.
March 18, 2008 Approval Letter - Adacel
To include unit dose syringes as an alternate presentation.
June 10, 2005 Approval Letter - Adacel
Booster immunization against tetanus, diphtheria and pertussis as a single dose in individuals 11 through 64 years of age.
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FDA Approves a New Combination Vaccine to Help Protect Both Adolescents and Adults against Whooping Cough[ARCHIVED]
Press Release: June 10, 2005