The Food & Drug Administration's Center for Biologics Evaluation and Research (CBER) regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products. It also approves the product labeling (package insert).
Please click below for the latest package inserts for licensed vaccines:
| Adenovirus |
Date |
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
|
April 1, 2014 |
| Anthrax |
Date |
BioThrax (Anthrax Vaccine Adsorbed)
|
November 23, 2015
|
| Chickenpox |
Date |
| ProQuad (MMRV) (prescribing information starts on page 2) |
October 23, 2018 |
Varivax (refrigerated) (prescribing information starts on page 2)
|
October 19, 2018
|
Varivax (frozen)
|
October 19, 2018
|
| Cholera |
Date |
| Vaxchora
|
June 10, 2016
|
| Haemophilus Influenzae type b (Hib) |
Date |
| ActHIB (prescribing information starts on page 2) |
May 24, 2019 |
Hiberix
|
April 30, 2018 |
PedvaxHIB
|
April 27, 2011 |
Pentacel
|
September 27, 2016 |
| Hepatitis A |
Date |
Havrix (prescribing information starts on page 2)
|
December 19, 2018
|
Twinrix (prescribing information starts on page 2)
|
December 18, 2018 |
| Vaqta (prescribing information starts on page 2) |
December 20, 2018 |
| Hepatitis B |
Date |
Engerix-B
|
December 19, 2018 |
| Heplisav-B |
March 22, 2018 |
Pediarix
|
April 25, 2016 |
Recombivax HB
|
December 21, 2018
|
Twinrix (prescribing information starts on page 2)
|
December 18, 2018
|
| Human Papillomavirus (HPV) |
Date |
| Gardasil 9 (prescribing information starts on page 2) |
October 5, 2018
|
| Influenza Seasonal |
Date |
| Afluria (Quadrivalent) (prescribing information starts on page 2) |
July 2, 2019 |
| Fluad (Trivalent) |
July 2, 2019 |
| Fluarix (Quadrivalent) |
July 2, 2019
|
| Flublok (Quadrivalent) (prescribing information starts on page 2) |
July 2, 2019 |
Flucelvax (Quadrivalent)
|
July 2, 2019 |
Flulaval (Quadrivalent) (prescribing information starts on page 2)
|
July 2, 2019
|
| FluMist (Quadrivalent) (prescribing information starts on page 2) |
July 15, 2019 |
Fluzone (Quadrivalent) (prescribing information starts on page 2)
|
July 2, 2019
|
Fluzone High-Dose (Trivalent) (prescribing information starts on page 2)
|
July 2, 2019
|
| Japanese Encephalitis |
Date |
| Ixiaro (prescribing information starts on page 2) |
October 4, 2018 |
| Meningococcal |
Date |
Bexsero (B)
|
May 31, 2018
|
Trumenba (B)
|
March 14, 2018 |
Menactra
|
April 27, 2018 |
Menveo (prescribing information starts on page 2)
|
October 4, 2018
|
| Measles-Mumps-Rubella |
Date |
M-M-R II
|
May 16, 2017 |
ProQuad (MMRV) (prescribing information starts on page 2)
|
October 23, 2018
|
| Pneumococcal |
Date |
Pneumovax 23
|
December 30, 2014
|
| Prevnar 13
|
August 22, 2017 |
| Polio |
Date |
IPOL
|
August 6, 2015
|
Kinrix
|
April 25, 2016
|
Pediarix
|
April 25, 2016
|
Pentacel
|
September 27, 2016 |
| Quadracel (prescribing information starts on page 2) |
June 11, 2019
|
| Rabies |
Date |
| Imovax |
July 3, 2013
|
| RabAvert
|
August 3, 2018 |
| Rotavirus |
Date |
Rotarix
|
April 25, 2016
|
RotaTeq
|
February 23, 2017 |
| Shingles |
Date |
Shingrix (prescribing information starts on page 2)
|
May 17, 2019
|
| Zostavax (refrigerated) (prescribing information starts on page 2) |
February 21, 2019 |
Zostavax (frozen) (prescribing information starts on page 2)
|
February 21, 2019 |
| Smallpox |
Date |
| ACAM2000
|
March 1, 2018
|
| Vaccinia Immune Globulin
|
January 1, 2010
|
| Tetanus-Diphtheria-Pertussis |
Date |
Adacel (prescribing information starts on page 2)
|
September 29, 2017
|
Boostrix
|
April 25, 2019
|
Daptacel
|
September 16, 2016
|
Diphtheria and Tetanus Toxoid Adsorbed (prescribing information starts on page 2)
|
December 20, 2018
|
Infanrix
|
April 28, 2016 |
| Kinrix
|
April 25, 2016
|
| Pediarix
|
April 25, 2016
|
Pentacel
|
September 27, 2016
|
| Quadracel (prescribing information starts on page 2) |
June 11, 2019 |
Tenivac
|
October 25, 2013
|
| Tuberculosis |
Date |
Aplisol
|
February 19, 2014 |
| Tubersol
|
April 22, 2016 |
| Typhoid |
Date |
| Typhim Vi
|
March 27, 2014
|
| Vivotif
|
September 1, 2013
|
| Yellow Fever |
Date |
| YF-VAX
|
June 15, 2016
|