PALO ALTO, Calif., Dec. 21 /PRNewswire-FirstCall/ -- Today, Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for Once-A-Day LUVOX(R) CR (fluvoxamine maleate) Extended-Release Capsules, for which Jazz Pharmaceuticals and Solvay Pharmaceuticals, Inc. are seeking marketing approval for the treatment of two anxiety disorders, social anxiety disorder (SAD) and obsessive compulsive disorder (OCD).
The FDA requested information related to the companies' response concerning the previously disclosed CMC issue. The companies are seeking clarification from FDA and look forward to working with FDA to resolve this as quickly as possible. The approvable letter did not raise any questions related to safety or efficacy of LUVOX(R) CR. The approvable letter included the FDA's proposed labeling.
Separately, the FDA approved LUVOX(R) (fluvoxamine maleate) for the treatment of OCD on December 20, 2007.
Jazz Pharmaceuticals will host an investor conference call and live
audio webcast to discuss this corporate update on December 24, 2007 at 8:30
a.m. Eastern Time/5:30 a.m. Pacific Time. The live webcast and press
release may be accessed on Jazz Pharmaceuticals' website at
http://www.JazzPharmaceuticals.com. Please connect to the website prior to
the start of the conference call to ensure adequate time for any software
downloads that may be necessary. An archived version of the webcast will be
available through January 7, 2008. Investors may participate in the
conference call by dialing 1-866-383-8009 in the U.S., or 1-617-597-5342
outside the U.S., and entering passcode 31811188. A replay of thi
|SOURCE Jazz Pharmaceuticals, Inc.|
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