Posted by Mystical on May 19, 2001, at 22:44:08
Pharmacia Receives “Not Approvable” Letter for VESTRA
~FDA Advisory committee to conduct review later this year~
Peapack, NJ (May 18, 2001) Pharmacia Corporation announced today that it has
received a “not approvable” letter from the U.S. Food and Drug Administration (FDA) for
VESTRA (reboxetine mesylate tablets), the company’s investigational antidepressant. The
company also announced that the FDA has agreed to convene an advisory committee
meeting of outside experts later this year to review the VESTRA submission.Pharmacia submitted its original NDA for VESTRA on April 29, 1998 based primarily on
the results of clinical studies conducted outside the U.S. At FDA’s request, the company
later conducted additional clinical studies in the U.S. and Canada. Results of these and
other previously completed studies supplemented the original filing at the FDA.VESTRA is a selective norepinephrine reuptake inhibitor (selective NRI) that affects the
norepinephrine chemical pathway in the brain. It is currently approved in 50 countries
around the world.Pharmacia Corporation (NYSE:PHA) is a top-tier global pharmaceutical company with a
leading agricultural subsidiary. Pharmacia’s innovative medicines and other products save
lives and enhance health and wellness. Pharmacia’s 59,000 people work together with
many diverse stakeholders to bring these benefits to people around the world, and to
create new health solutions for the future.
Analyst Contact :
Craig Tooman
Ph: (908) 901-8853
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Company: Pharmacia Corporation
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Media Contact :
Gail Thornton
Ph: (908) 901- 8598
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Company: Pharmacia Corporation
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Media Contact :
Paul Fitzhenry
Ph: (908) 901-8770
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Company: Pharmacia Corporation
Email: N/A==================================================== AFTER ALL OUR WAITING, THIS IS REAL BUMMER! I THINK WE WE NEED TO START A REAL STRONG PHONE-IN AND WRITE-IN MOVEMENT TO THE FDA. WHAT DO YOU THINK? BRAD
poster:Mystical
thread:63666
URL: http://www.dr-bob.org/babble/20010515/msgs/63666.html