Navigation Links
Jazz Pharmaceuticals Announces Paragraph IV ANDA Filing for Xyrem
Date:10/5/2010

PALO ALTO, Calif., Oct. 5 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced that the website of the US Food and Drug Administration indicates that an Abbreviated New Drug Application (ANDA) for a generic version of Xyrem® (sodium oxybate oral solution) 500 mg/ml was submitted on July 8, 2010.  Jazz Pharmaceuticals has not received a Paragraph IV certification with respect to this filing.

Jazz Pharmaceuticals intends to vigorously enforce its intellectual property rights.  Xyrem is protected by seven patents covering its formulation and the company's distribution system for the product, including five patents listed in the FDA's Approved Drug Products List (the Orange Book).  

About Jazz Pharmaceuticals, Inc.

Jazz Pharmaceuticals is a specialty pharmaceutical company focused on identifying, developing and commercializing innovative products to meet unmet medical needs in neurology and psychiatry. For further information see www.JazzPharmaceuticals.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements, including, but not limited to, Jazz Pharmaceuticals' intent to vigorously enforce its intellectual property rights.  These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties.  Jazz Pharmaceuticals' actual results could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the ability of the company to protect its intellectual property and defend its patents, the possible introduction of generic products, the dependence of the company on sales of Xyrem, and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals' Securities and Exchange Commission filings and reports, including in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on August 11, 2010. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.


'/>"/>
SOURCE Jazz Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Ground Zero Pharmaceuticals Announces Expansion of Global Consulting in Somatic Cell Therapies
2. OncoGenex Pharmaceuticals to Present at the 9th Annual BIO Investor Forum
3. Access Pharmaceuticals Furthers Progress on Its Cobalamin-mediated Targeted Drug Delivery Platform for siRNA
4. Syndax Pharmaceuticals to Present at BIO Investor Forum
5. ISTA Pharmaceuticals Highlights Clinical Data from REMURAâ„¢ Phase 2 Study Presented at the 6th International Conference on the Tear Film & Ocular Surface
6. Jiangbo Pharmaceuticals Announces Conference Call to Discuss Results for Fourth Quarter Fiscal 2010
7. OncoGenex Pharmaceuticals, Inc. - Journal of Clinical Oncology Publishes Data from Randomized Phase 2 Custirsen Trial
8. TOPICA Pharmaceuticals Announces Sublicensing Agreement for Tinea Indication
9. Keryx Biopharmaceuticals to Present at the UBS 2010 Global Life Sciences Conference
10. Optimer Pharmaceuticals Phase 3 Clinical Trials show Fidaxomicin is Superior to Vancomycin in Treatment of Recurrent Clostridium difficile Infection (CDI); Data Presented at ICAAC
11. Edimer Pharmaceuticals and CMC Biologics Announce Agreement to Manufacture EDI200 Recombinant Protein
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/9/2016)... 9, 2016 /PRNewswire/ - Portage Biotech Inc. ("Portage" or ... pleased to announce that Biohaven has issued today the ... Connecticut (PRWEB) Dec 9, 2016 - Biohaven ... today that the U.S. Food and Drug Administration ("FDA") ... its drug candidate BHV-0223, an orally dissolving tablet being ...
(Date:12/8/2016)... PITTSBURGH , Dec. 8, 2016  The Board ... (PLSG), Western Pennsylvania,s only ... in leadership. In accordance with the succession plan developed ... several years, effective today, James (Jim) F. Jordan ... Executive Officer, succeeding John W. Manzetti , who ...
(Date:12/8/2016)... (PRWEB) , ... December 08, 2016 , ... Lajollacooks4u, San ... a banner year for team building events, new program offerings and company expansion. ... expanded earlier this year to include groups of over 30 people. Ever since, Lajollacooks4u ...
(Date:12/8/2016)... (PRWEB) , ... December 08, 2016 , ... ... platforms, the business of innovation is taking over sports. On Thursday, December 15th ... explore how technology is disrupting the playing field at a Smart Talk session. ...
Breaking Biology Technology:
(Date:11/29/2016)... 2016   Neurotechnology , a provider ... technologies, today released FingerCell 3.0, a software ... that run on low-power, low-memory microcontrollers. FingerCell ... than 128KB of memory, enabling it to ... limited on-board resources, such as: mobile phones, ...
(Date:11/22/2016)... 2016 According to the new market research report ... Vein, Signature, Voice), Multi-Factor), Component (Hardware and Software), Function (Contact and Non-contact), ... market is expected to grow from USD 10.74 Billion in 2015 to ... 2016 and 2022. Continue Reading ... ...
(Date:11/17/2016)... , Nov. 17, 2016 Global Market Watch: ... Biobanks (Disease-Based Banks, Population-Based Banks and Academics) market is to ... for Private Biobanks shows the highest Compounded Annual Growth Rate ... region during the analysis period 2014-2020. North ... of 9.95% followed by Europe at ...
Breaking Biology News(10 mins):