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Article: FUZEON(TM) Granted Priority Review Status by U.S. FDA.
- Article from:
- PR Newswire
- Article date:
- October 11, 2002
CopyrightCOPYRIGHT 2002 PR Newswire Association LLC. 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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- First HIV fusion inhibitor will have a target six month review period -
Roche and Trimeris, Inc. today announced that the U.S. Food and Drug Administration (FDA) has notified the companies that the New Drug Application (NDA) for FUZEON(TM) (generic: enfuvirtide, formerly known as T-20) is fileable and has been granted priority review status. Designed for the treatment of HIV-1 in combination with other antiretroviral agents, FUZEON is the most clinically advanced in an investigational class of anti-HIV drugs called "fusion inhibitors."
The priority review designation establishes a target six-month review period for the FUZEON NDA, which was submitted ...