Zostavax
Generic name: zoster vaccine live
Treatment for: Herpes Zoster, Prophylaxis
Merck Submits Biologics License Application to FDA for Zostavax, an Investigational Vaccine for Shingles and Shingles-Associated Nerve Pain
WHITEHOUSE STATION, N.J., May 2, 2005 - Merck & Co., Inc. announced today that it has submitted to the U.S. Food and Drug Administration (FDA) a Biologics License Application for Zostavax (zoster vaccine live (Oka/Merck)), an investigational vaccine for the prevention of herpes zoster, commonly known as "shingles;" prevention of postherpetic neuralgia (PHN), the persistent, long-term nerve pain that is the most common complication of shingles; and the reduction of acute and chronic shingles-associated pain in adults.
Merck submitted the application for Zostavax on April 25. Within the next 60 days, the FDA will determine whether it will accept for review Merck's application as submitted.
About Shingles and Postherpetic Neuralgia
Shingles occurs when the varicella-zoster virus that causes chickenpox reactivates after lying dormant in the body, typically after several decades. Shingles may first appear as tingling, itching or pain on one side of the body or face. It then progresses to a blistering rash accompanied by pain in almost every case that varies in intensity and duration. Shingles also can lead to complications, including persistent, often debilitating nerve pain (PHN) that can follow an episode of shingles. Approximately 25 to 50 percent of shingles patients older than 50 years of age develop chronic pain after shingles (PHN).
Shingles can affect anyone who has had chickenpox -- more than 90 percent of adults in the United States -- and occurs most frequently in people over 50 years of age. In fact, up to half of all people living to age 85 will develop shingles during their lifetime. It is estimated that up to 800,000 people in the United States suffer from shingles each year, and the incidence is expected to increase as the population ages.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in more than 20 therapeutic categories. The company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service.
Posted: May 2005
Related articles
- FDA Expands Indication for Zostavax, Merck's Shingles Vaccine, to Include Adults Ages 50 to 59 - March 25, 2011
- FDA Review Date for Merck's Investigational Shingles Vaccine Extended to May 25, 2006 - February 24, 2006
- 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 - December 15, 2005
- Merck Announces that FDA Has Accepted For Review Biologics License Applications for Rotateq and Zostavax - June 29, 2005
Zostavax (zoster vaccine live) FDA Approval History
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