Navigation Links
Zogenix Reports FDA Provides New PDUFA Date for Sumavel(TM) DosePro(TM)
Date:2/18/2009

SAN DIEGO, Feb. 18 /PRNewswire/ -- Zogenix, Inc. ("Zogenix"), a private, specialty pharmaceutical company, announced that the U.S. Food & Drug Administration (FDA) has provided a target date of July 15, 2009 for completion of its review of the NDA for Sumavel DosePro (sumatriptan injection) needle-free delivery system. Zogenix is seeking marketing approval of Sumavel DosePro for the acute treatment of migraine attacks with or without aura, and the acute treatment of cluster headache episodes.

In October, the company received a Complete Response letter from the FDA citing the need for a single additional in vitro test to be conducted. Zogenix recently submitted this information to the FDA. The FDA has accepted this resubmission as a complete response, providing the new Prescription Drug User Fee Act (PDUFA) review date of July 15, 2009.

Sumavel DosePro uses the novel, proprietary DosePro drug delivery system to subcutaneously administer sumatriptan, a medication that has been used to treat migraines effectively and safely for over fifteen years, but without many of the issues associated with needle delivery. Sumavel DosePro has the potential of offering migraine relief beginning in as little as ten minutes, in a system sufferers can self administer in three easy steps. Given the unique attributes of Sumavel DosePro, Zogenix believes it has the potential to be used as a replacement for needle-based injectable forms of sumatriptan, as well as to replace tablet and nasal spray triptans for challenging migraine episodes.

Migraine affects approximately 30 million people in the United States. Patients suffer with extreme pain, nausea, vomiting, and sensitivity to light and sound, making it difficult to undertake work or other activities. Because of this, speed of relief is a key attribute identified by migraine patients when choosing a medication.

"We look forward to working w
'/>"/>

SOURCE Zogenix, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Senesco Technologies Reports Second Quarter Fiscal 2009 Financial Results
2. Gentiva Reports Fourth Quarter and Fiscal 2008 Results
3. Idenix Pharmaceuticals Reports Fourth Quarter and Year End Financial Results
4. Genesis Pharmaceuticals Reports Results for the Second Quarter of its Fiscal Year 2009
5. Pharmacyclics Reports Second Quarter Fiscal 2009 Financial Results
6. YM BIOSCIENCES REPORTS SECOND QUARTER 2009 OPERATIONAL AND FINANCIAL RESULTS
7. Shengtai Pharmaceutical, Inc. Reports Second Quarter Fiscal 2009 Financial Results
8. Neurobiological Technologies Reports Second Quarter Fiscal 2009 Financial Results
9. Corgenix Reports Second Quarter Fiscal 2009 Financial Results
10. Sigma-Aldrich (Nasdaq: SIAL) Reports Fourth Quarter Diluted EPS of $0.68. Ends 2008 With Record Sales and Earnings and Raises Quarterly Cash Dividend by 11.5%. Provides Outlook for 2009.
11. Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2008 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... MD (PRWEB) December 23, 2014 ... into law H.R. 83, the Omnibus and Continuing ... first time, made hydrocephalus a condition eligible to ... Programs (CDMRP) administered by the Department of Defense ... with its allies on Capitol Hill, is celebrating ...
(Date:12/24/2014)... The report expects global cell isolation and expansion market ... a carefully analyzed data about the vital drivers, restraints, ... Full Copy of Report @ http://bit.ly/1yUxy0T , ... expansion will keep witnessing growth at an impressive CAGR ... driven by rapid technological advancements, government funding and investments, ...
(Date:12/24/2014)... PharmaBoardroom,s new report, , Healthcare and ... free download , digs deep into this vibrant market, ... sector today. One area where Algeria ... a homegrown pharmaceutical manufacturing base, even if the government,s ambitious ... off. A cursory comparison with neighboring Morocco ...
(Date:12/22/2014)... 2014 The Center for Professional ... technical training across the life sciences industry, has partnered ... (SCDM) to provide the organization's members with discounted classroom ... to the more than 350 sessions across 80 course ... off when registering for a public course ...
Breaking Biology Technology:Rare Brain Condition Now Eligible for Department of Defense Research Dollars 2The Cell Expansion Market is Expected to Reach $14.8 billion by 2019 - New Research Report by MarketsandMarkets 2The Cell Expansion Market is Expected to Reach $14.8 billion by 2019 - New Research Report by MarketsandMarkets 3PharmaBoardroom Releases New Algeria Pharmaceuticals Report 2PharmaBoardroom Releases New Algeria Pharmaceuticals Report 3CfPIE Announces Partnership with the Society for Clinical Data Management 2CfPIE Announces Partnership with the Society for Clinical Data Management 3
... In a video interview, new CEO,Andrew Witty comments on ... strategic vision for the business., The ... diversified global business - Deliver more products of value ... and vodcast are available now on, http://www.cantos.com . It,s free ...
... 23 Duska Therapeutics,Inc. (OTC Bulletin Board: DSKA) ... a synopsis of a proposed Phase 3 clinical ... Food and Drug Administration,s (the,"FDA") Division of Cardiovascular ... with the FDA, including a face-to-face,meeting held on ...
... Next generation design reduces the amount of retraction needed for surgical ... ... July 23 Pioneer Surgical Technology,today announces the market availability of ... optimize,anterior cervical fusion procedures while addressing the clinical needs of,anterior cervical ...
Cached Biology Technology:Duska Therapeutics Submits Phase 3 ATPace(TM) Protocol to FDA for Comment 2Duska Therapeutics Submits Phase 3 ATPace(TM) Protocol to FDA for Comment 3Duska Therapeutics Submits Phase 3 ATPace(TM) Protocol to FDA for Comment 4Pioneer(R) Surgical Technology, Inc. Announces the Market Launch of the SlimFuse(TM) Anterior Cervical Plate System 2
(Date:11/21/2014)... Nov. 19, 2014  Earlier this year Donald ... College, and one of the most prolific inventors in ... are transmitted from Smartphones to third party agencies. Spector ... has one of the earliest known patents in this ... in the military, child care, elder care and hospital ...
(Date:11/21/2014)... C-Labs LLC, a leading provider of remote ... today announced the appointment of John Traynor ... strategic advisor to the firm, Mr. Traynor will now ... based out of the C-Labs office in ... Muench , Chief Executive Officer. Photo - ...
(Date:11/18/2014)...  The Secure Identity & Biometrics Association (SIBA) ... the formation of The Airport Entry and Exit ... and Biometric Entry and Exit Solutions Framework for ... from BORDERPOL, the international non-profit organization that works ... regarding border security, traveler and migration systems. ...
Breaking Biology News(10 mins):Patented Biosensor Wearable Technology Provides a More Civilized Method of Quarantine 2Patented Biosensor Wearable Technology Provides a More Civilized Method of Quarantine 3Patented Biosensor Wearable Technology Provides a More Civilized Method of Quarantine 4C-Labs Names Former Microsoft and Bsquare Executive as Chief Operating Officer 2Identity Management, Document Authentication and Biometric Companies Form "The Airport Entry and Exit Working Group", Releasing the Framework to Help Guide the Department of Homeland Security and Congress Towards Solutions 2Identity Management, Document Authentication and Biometric Companies Form "The Airport Entry and Exit Working Group", Releasing the Framework to Help Guide the Department of Homeland Security and Congress Towards Solutions 3
... of the International Society for Sexually Transmitted Disease Research ... City, Canada. The world,s foremost conference in the ... from every continent to discuss the most recent developments ... emerging threats in bacterial STDs; major intervention programs for ...
... University of Georgia researcher has invented a new ... clothing, face masks, paper towelsand yes, even diapers, ... germ-free. The simple and inexpensive anti-microbial technology ... can be applied during the manufacturing process or ...
... are developing new technologies that combine a laser ... particles such as bacteria, viruses and DNA for ... to food safety. The technologies could bring ... or miniature instruments that perform measurements normally requiring ...
Cached Biology News:New UGA technology makes textiles permanently germ-free; targets health care-associated infections 2New UGA technology makes textiles permanently germ-free; targets health care-associated infections 3Laser, electric fields combined for new 'lab-on-chip' technologies 2Laser, electric fields combined for new 'lab-on-chip' technologies 3
Guanylate Kinase Purified Anti-Mouse, Anti-Rat clone 28, Isotype Mouse IgG 1 , 50 µg Consult technical datasheet for details....
Proliferin (C-14)...
... the computing power of your ValveBank system! ... sequences with a Macintosh computer using graphic ... to disk, print out program listings, then ... in one simple step., EasyCode is used ...
... series of Class II Biological Safety ... certification to the world's highest safety ... the cabinets cannot be adjusted out ... low noise and arm rest ensure ...
Biology Products: