The FDA evaluated a data package involving approximately 600 patients
worldwide that included three clinical trials with positive outcomes
evaluating the efficacy and safety of LUVOX CR. These studies were:
Social Anxiety Disorder
-- Davidson, Jonathan, et al. Fluvoxamine-controlled release formulation
for the treatment of generalized social anxiety disorder. J Clin
Psychopharmacol 2004; 24:118-125.
-- Westenberg, Herman, et al. A double-blind, placebo-controlled study of
controlled-release fluvoxamine for the treatment of generalized social
anxiety disorder. J Clin Psychopharmacol. 2004; 24:49-55.
Obsessive Compulsive Disorder
-- Hollander, Eric, et al. A double-blind, placebo-controlled study of
the efficacy and safety of controlled-release fluvoxamine in patients
with obsessive-compulsive disorder. J Clin Psychiatry. 2003;
"SAD and OCD are serious, yet treatable conditions," said Jerilyn Ross, M.A., L.I.C.S.W., president and CEO, Anxiety Disorders Association of America (ADAA). "We're excited about new treatment options -- both medications and psychological -- to help patients with these chronic and undertreated anxiety disorders. Having treatment options benefits the patient, and that's what is most important."
LUVOX CR will be available in 100 mg and 150 mg dose strengths. Over the next several weeks, Jazz Pharmaceuticals will continue to work closely with Elan on the manufacturing of LUVOX CR for commercial launch.'/>"/>
|SOURCE Jazz Pharmaceuticals, Inc.|
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