Prevnar 13 Approval History

  • FDA approved: Yes (First approved February 24th, 2010)
  • Brand name: Prevnar 13
  • Generic name: pneumococcal 13-valent conjugate vaccine
  • Company: Wyeth Pharmaceuticals Inc.
  • Treatment for: Pneumococcal Disease Prophylaxis

Prevnar 13 (pneumococcal 13-valent conjugate vaccine) is a vaccine indicated for active immunization against invasive pneumococcal disease in infants, young children and adults ages 50 and older.

FDA Approval History for Prevnar 13

DateArticle
Jan 25, 2013Approval Pfizer Receives FDA Approval For The Use Of Prevnar 13 In Vaccine-Naive Children And Adolescents Aged 6 Years Through 17 Years For The Prevention Of Invasive Pneumococcal Disease
Jan  3, 2012Approval FDA Expands Use of Prevnar 13 Vaccine for People Ages 50 and Older
Feb 24, 2010Approval FDA Approves Prevnar 13 Pneumococcal Disease Vaccine
Jan  5, 2010Pfizer Provides U.S. Regulatory Update On Prevnar 13 Vaccine
Aug 12, 2009Wyeth Provides Regulatory Update on Prevnar 13 in the United States
Mar 31, 2009Wyeth Submits Marketing Application to FDA for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in Infants and Toddlers

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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