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Article: Gardasil gets FDA nod for cervical cancer.(United States Food and Drug Administration)(Brief article)
- Article from:
- Pharma Marketletter
- Article date:
- May 29, 2006
CopyrightCOPYRIGHT 2006 Marketletter Publications Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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USA-based pharmaceutical major Merck & Co's cervical cancer vaccine Gardasil (recombinant quadrivalent human papillomavirus; Types 6, 11, 16, 18 is one step closer to approval after the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee unanimously voted that it is safe and effective.
The FDA committee agreed that Phase II and III trial data supports the agent's approval for the prevention of precancers and other cervical, vulvar and vaginal lesions caused by HPV types 6, 11, 16 and 18, including genital warts. Its guidance will be considered by the agency in its review of Merck's December 2005 Biologics License ...