FROM:Letter on the CDC & FDA via NewsRx.com & NewsRx.net
August 8, 2004
SECTION: EXPANDED REPORTING; Pg. 92
HEADLINE: PRODUCT LICENSING;
Teva receives approvable letter for Agilect for Parkinsons
Teva Pharmaceutical Industries Ltd. (TEVA) has received notice the
its
application is approvable from the U.S. Food & Drug Administration
(FDA) for
once-daily AGILECT (rasagiline mesylate) as a treatment for Parkinson
disease as
initial monotherapy in early PD patients and as adjunct therapy to
levodopa in
moderate to advanced stages of the disease.
Following the approvable letter, Teva will work with the FDA to
complete the
process of receiving final approval as soon as possible.
Israel Makov, president and CEO, Teva, said the company is "pleased
to
receive this approvable letter, which is a major regulatory milestone in
the
approval process."
Teva Neuroscience, Inc. and Eisai Inc. will co-promote AGILECT in the
United
States once approved by the FDA, and Teva and H. Lundbeck A/S will
co-promote
the product in Europe, once approved there.
This article was prepared by Medical Letter on the CDC & FDA
editors from
staff and other reports. Copyright 2004, Medical Letter on the CDC &
FDA via
NewsRx.com & NewsRx.net.
LOAD-DATE: July 30, 2004
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