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Zostavax Approval History

  • FDA approved: Yes (First approved May 25th, 2006)
  • Brand name: Zostavax
  • Generic name: zoster vaccine live
  • Dosage form: Injection
  • Company: Merck & Co., Inc.
  • Treatment for: Herpes Zoster, Prophylaxis

Zostavax (zoster vaccine live) is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older.

Development History and FDA Approval Process for Zostavax

Mar 25, 2011Approval FDA Expands Indication for Zostavax, Merck's Shingles Vaccine, to Include Adults Ages 50 to 59
Feb 24, 2006FDA Review Date for Merck's Investigational Shingles Vaccine Extended to May 25, 2006
Dec 15, 2005FDA Advisory Committee Agrees that Clinical Data Support the Efficacy and Safety of Zostavax, Merck's Investigational Vaccine for Shingles, in Adults Aged 60 and Older
Jun 29, 2005Merck Announces that FDA Has Accepted For Review Biologics License Applications for Rotateq and Zostavax
May  2, 2005Merck Submits Biologics License Application to FDA for Zostavax, an Investigational Vaccine for Shingles and Shingles-Associated Nerve Pain

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