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Jazz Pharmaceuticals' unrestricted cash, cash equivalents and
marketable securities balance as of December 31, 2007 was $102.9 million.
Net operating cash used during the year ended December 31, 2007 was $81.1
million.
Recent Highlights
-- On January 31, 2008, Jazz Pharmaceuticals announced that the U.S. Food
and Drug Administration (FDA) had accepted for review the submission of
the response by Solvay Pharmaceuticals, Inc. to the FDA approvable
letter for LUVOX CR. The FDA notified Solvay Pharmaceuticals that it
considered this a complete, class 1 response and the PDUFA action date
is February 29, 2008. In an approvable letter received on
December 21, 2007, the FDA had requested additional information
concerning a chemistry, manufacturing and control (CMC) issue. The
approvable letter did not raise any questions related to safety or
efficacy of LUVOX CR and included the FDA's proposed labeling. Jazz
Pharmaceuticals and Solvay Pharmaceuticals believe that the response
submitted to the FDA on December 28, 2007 fully addressed that CMC
issue.
-- Jazz Pharmaceuticals has completed the expansion of its sales force,
and now has a total of approximately 200 field sales personnel,
including sales management and sales representatives. These
individuals are currently in their assigned sales territories promoting
Xyrem.
-- In early January 2008, Jazz Pharmaceuticals announced that it had
received orphan drug designation from the FDA for its JZP-8 product
candidate for the treatment of recurrent acute repetitive seizures.
JZP-8 is a novel drug delivery formulation incorporating clonazepam, a
widely prescribed benzodiazepine. The product candidate is designed to
be a fast-acting intranasal spray for the treatment of re
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