Zostavax Approval History
FDA Approved: Yes (First approved May 25, 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, 2011|| FDA Expands Indication for Zostavax, Merck's Shingles Vaccine, to Include Adults Ages 50 to 59|
|Feb 24, 2006||FDA Review Date for Merck's Investigational Shingles Vaccine Extended to May 25, 2006|
|Dec 15, 2005||FDA 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, 2005||Merck Announces that FDA Has Accepted For Review Biologics License Applications for Rotateq and Zostavax|
|May 2, 2005||Merck Submits Biologics License Application to FDA for Zostavax, an Investigational Vaccine for Shingles and Shingles-Associated Nerve Pain|
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