Advertisement
LUVOX CR(R) was approved on February 28, 2008 by the U.S. Food and DrugAdministration (FDA) for the treatment of social anxiety disorder (SAD) andobsessive compulsive disorder (OCD) in adults. The patent has been listed forLUVOX CR(R) in the FDA Orange Book.
Advertisement
About the FDA Orange Book
The FDA's Approved Drug Products List with Therapeutic EquivalenceEvaluations, commonly referred to as the Orange Book, lists all drug productsthat have been approved by FDA for safety and effectiveness. The Orange Bookalso includes information on patents which claim an approved drug product ormethod of use of the drug product, to facilitate the legal requirement thatgeneric drug applicants include an appropriate certification to each suchpatent as part of any Abbreviated New Drug Application (ANDA) for a genericversion of a listed drug.
About Elan Drug Technologies
Elan's Drug Technologies group has developed LUVOX CR using one of itsproprietary Oral Controlled Release Technologies, the SODAS(R) (SpheroidalOral Drug Absorption System) Technology. Elan Drug Technologies (EDT) is anestablished, profitable and growing specialty pharmaceutical business unit ofElan Corporation, plc. For nearly 40 years, EDT has been applying its skillsand knowledge to enhance the performance of dozens of drugs that have beenmarketed worldwide. EDT is focused on using its extensive experience,proprietary drug delivery technologies and licensing capabilities to developinnovative products that deliver clinically meaningful benefits to patients.More information about EDT's broad range of technologies including their OralControlled Release and NanoCrystal(R) Technology Platforms, and its range ofservices is available at http://www.elan.com/EDT.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is a specialty pharmaceutical company thatidentifies, develops and commercializes innovative treatments for important,underserved markets in neurology and psychiatry. The Company has an unwaveringcommitment to improving care for patients with serious psychiatric andneurological conditions through innovative treatments and distinctive andvaluable programs for patients and physicians. For further information seehttp://www.JazzPharmaceuticals.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Actof 1995
This press release contains forward-looking statements, including, but notlimited to, statements related to LUVOX CR(R). These forward-lookingstatements are based on the company's current expectations and inherentlyinvolve significant risks and uncertainties. Jazz Pharmaceuticals' actualresults and the timing of events could differ materially from thoseanticipated in such forward-looking statements as a result of these risks anduncertainties, which include, without limitation, the risk that ourintellectual property rights may not ensure protection of our products and therisk that our products might infringe the intellectual property rights ofothers. These and other risk factors are discussed under "Risk Factors" inthe Quarterly Report on Form 10-Q for the quarter ended September 30, 2008filed by Jazz Pharmaceuticals with the Securities and Exchange Commission onNovember 14, 2008. Jazz Pharmaceuticals undertakes no duty or obligation toupdate any forward-looking statements contained in this release as a result ofnew information, future events or changes in its expectations.
SODAS(R) and NanoCrystal(R) are registered trademarks of Elan PharmaInternational Limited, Ireland, a subsidiary of Elan Corporation, plc(NYSE: ELN).
LUVOX CR(R) is a registered trademark of Solvay Pharmaceuticals, Inc.
SOURCE Jazz Pharmaceuticals, Inc.
