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| FDA Product Approvals and
Press Releases - 2010 |
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| FDA: Influenza Virus Vaccine for the
2010-2011 Season |
| Released: 3/2/10 |
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| FDA News Release and
Package Insert: Pneumococcal 13-valent conjugate vaccine offers
broader protection |
| Released: 2/24/10 |
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| FDA Product Approval and
Package Insert: Menveo (Novartis), meningococcal conjugate vaccine for
people ages 11 through 55 years |
| Released: 2/19/10 |
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| FDA Press Release:
Collaboration with PATH seeks to speed development of pneumococcal
vaccines for children in developing countries |
| Released: 2/1/10 |
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| Letter from the FDA
Commissioner to Nation's Health Care Professionals on H1N1 Vaccine
Safety |
| Released: 1/14/10 |
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| FDA Product Approvals and Press Releases - 2009 |
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| FDA Press Release and
Package Insert: Fluzone high-dose seasonal influenza vaccine approved,
specifically intended for people ages 65 and older |
| Released: 12/23/09 |
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| FDA Product Approval and
Package Insert: FDA approves Agriflu (Novartis) seasonal influenza
vaccine |
| Released: 11/27/09 |
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| FDA Product Approval: 2009
H1N1 influenza vaccine, manufactured by ID Biomedical Corp |
| Released: 11/16/09 |
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| FDA Supplemental Approval:
Seasonal influenza vaccine, Afluria (CSL Limited) indication expanded
to include infants, children, and teens age 6 months and older |
| Released: 11/10/09 |
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| FDA Supplemental Approval:
H1N1monovalent vaccine (CSL Limited) indication expanded to include
infants, children, and teens age 6 months and older |
| Released: 11/10/09 |
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| Dear Healthcare Professional
Letter about H1N1 Vaccine from FDA Commissioner Margaret Hamburg |
| Released: 11/10/09 |
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| FDA Approval Letter:
Influenza virus vaccine (Fluarix, GlaxoSmithKline) indication expanded
to include children and teens |
| Released: 10/19/09 |
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| FDA Press Release and
Package Insert: FDA approves new vaccine (Cervarix, GlaxoSmithKline)
for the prevention of cervical cancer |
| Released: 10/16/09 |
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| FDA Approves New Indication
for Gardasil to Prevent Genital Warts in Men and Boys |
| Released: 10/16/09 |
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| FDA Public Health Alert:
Potential medication errors with influenza drug (oseltamivir/Tamiflu)
for oral suspension |
| Released: 9/25/09 |
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| FDA News Release: Agency approves four
vaccines against the 2009 H1N1 influenza virus |
| Released: 9/15/09 |
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| FDA Press Release and Package Insert:
Accelerated approval of Hib vaccine (Hiberix) to help sustain adequate
vaccine supply |
| Released: 8/19/09 |
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| FDA Press Release: 2009-2010 seasonal
influenza vaccine approved |
| Released: 7/20/09 |
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| Recall of lot number D50002 Prevnar PCV7;
no safety risk associated with this voluntary recall |
| Released: 7/10/09 |
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FDA updates Gardasil label, now
includes information about syncope |
|
Released: 6/9/09 |
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HHS takes additional steps toward
development of 2009 H1N1 influenza vaccine |
| Released: 5/22/09 |
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| FDA Press Release: FDA authorizes
emergency use of influenza medicines, diagnostic test in response to swine
flu outbreak |
| Released: 4/27/09 |
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| FDA Product Approval and Package Insert:
FDA approves new vaccine to prevent Japanese encephalitis |
| Released: 3/30/09 |
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| FDA: Influenza Virus Vaccine 2009-2010
Season |
| Released: 2/09 |
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| FDA Product Approvals and Press Releases - 2008 |
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| FDA Supplemental Approval: Changes in the
schedule for administering anthrax vaccine and in the route of
administration |
| Released: 12/11/08 |
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| FDA Product Approval: Boostrix Tdap
vaccine indication expanded and approved for use in individuals 10 through
64 years of age |
| Released: 12/4/08 |
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| FDA Release: Importance of Influenza
Vaccination for Health Care Personnel |
| Released: 11/20/08 |
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| FDA Consumer Health Information: Addressing Questions about Gardasil |
| Released: 9/29/08 |
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| FDA Consumer Health Information: Vaccines Stand Ready for Flu Season |
| Released: 9/26/08 |
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| Product Approval: FDA approves 2008-2009 influenza vaccines |
| Released: 8/05/08 |
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| Information from FDA and CDC on gardasil and its safety |
| Released: 7/22/08 |
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| Product Approval: DTaP-IPV vaccine (KINRIX) approved for use in children ages 4 through 6 years as the fifth dose in the DTaP vaccine series and the fourth dose in the IPV series |
| Released: 6/24/08 |
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| Product Approval: Pentacel (sanofi pasteur), a new combination vaccine containing diphtheria and tetanus toxoids, acellular pertussis, inactivated poliovirus and Hib (DTaP-IPV/Hib) approved for ages 6 weeks through 4 years |
| Released: 6/20/08 |
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| Product Approval: FDA approves use of Td (Tenivac) in adults age 60 years and older |
| Released: 6/08/08 |
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| Product Approval: FDA approves new rotavirus vaccine |
| Released: 4/06/08 |
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| FDA selects the influenza virus strain composition of next season's (2008-2009) influenza vaccine for use in the United States |
| Released: 2/21/08 |
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| FDA Product Approvals and Press Releases - 2007 |
Back to top |
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| Press Release: FDA expands age range for use of bacterial meningitis vaccine to include children ages 2 to 10 years |
| Released: 10/18/07 |
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| Press Release: Additional influenza vaccine (Afluria, CSL Limited, Parkville, Australia) approved for upcoming influenza season |
| Released: 9/28/07 |
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| Press Release: Nasal influenza vaccine (FluMist) licensure expanded to include use in younger children (between 2 and 5 years of age) |
| Released: 9/19/07 |
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| Press Release: New second-generation smallpox vaccine licensed |
| Released: 9/01/07 |
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