Navigation Links
FDA Approves Aloxi(R) (Palonosetron HCL) Injection for Prevention of Postoperative Nausea and Vomiting
Date:3/2/2008

WOODCLIFF LAKE, N.J., March 2 /PRNewswire/ -- Eisai Corporation of North America, its U.S. subsidiary, MGI PHARMA, INC., and Helsinn Healthcare SA today announced that the U.S. Food and Drug Administration (FDA) has approved Aloxi(R) (palonosetron hydrochloride) injection for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.

Aloxi, available in the United States since 2003, is the first and only 5-hydroxytryptamine-3 (5-HT3) receptor antagonist approved by the FDA for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and for the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy.

The new indication is based on one double-blind Phase III study that evaluated the efficacy of three doses of Aloxi compared to placebo for the prevention of PONV. In the trial, 574 patients undergoing elective gynecologic or abdominal laparoscopic surgery (predominately in the out-patient setting) were randomized to receive one of three single intravenous doses of Aloxi (0.025 mg, 0.050 mg or 0.075 mg) or placebo prior to administration of anesthesia. The effectiveness of Aloxi in PONV was assessed on the day of surgery (0-24 hours) and for two subsequent days (24-72 hours).

The trial successfully met its co-primary endpoint of Complete Response (CR) - defined as no emesis (vomiting) or use of rescue medication - for the 0-24-hour time period (42.8% of patients treated with the approved dose of Aloxi 0.075 mg experienced a CR, compared to 25.9% of patients given placebo [p=0.0035]). For the co-primary endpoint of CR for the 24-72-hour postoperative period, 48.6% of patients treated with Aloxi 0.075 mg experienced a CR, compared to 40.7% of patients given placebo (p=0.1877, not significant).

Further, Aloxi 0
'/>"/>

SOURCE Eisai Corporation of North America
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine news :

1. FDA Approves Luvox(R) CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder (SAD) and Obsessive Compulsive Disorder (OCD)
2. FDA Approves NEXIUM(R) for the Treatment of Short-Term GERD in Children 1 to 11 Years Old
3. U.S. Court Approves AK Steels VEBA Health Care Settlement With Middletown Works Retirees
4. Securian Board Approves 8 Officer Promotions
5. MGT Capital Investments, Inc. Approves Share Buyback Program
6. Kaiser Permanente Approves $29 Million in Community Benefit Grants
7. Otter Tail Corporation Reports Record Revenues and Net Income From Continuing Operations for 2007; Earnings Per Share of $1.78; Board Approves Dividend Increase
8. Pennsylvania Attorney General Approves Vincentian Collaborative System-Marian Manor Integration
9. FDA Approves ASMANEX (R) TWISTHALER(R) (Mometasone Furoate Inhalation Powder) for the Once Daily Maintenance Treatment of Asthma in Children Ages 4-11
10. FDA Approves Additional Indication for Astellas MYCAMINE(R)
11. FDA Approves Labeling Change for Non-Drowsy CLARITIN(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/16/2014)... (PRWEB) September 16, 2014 The rapidly ... concern for health plans, employers and PBMs as spending ... of their drug lists. Once a concentrated, patient-specific practice, ... 25 webinar from Atlantic Information Services, Inc. (AIS), ... will offer details of what one leading health ...
(Date:9/16/2014)... (PRWEB) September 16, 2014 ... Health and Safety (EHS) and Sustainability management software, ... newest and most versatile software platform, MobileWorkflows, at ... October. , MobileWorkflows allow for on-the-go access ... the principles of Responsive Web Design, MobileWorkflows feature ...
(Date:9/16/2014)... (PRWEB) September 16, 2014 DiaperBuys, a ... honoring ‘Healthy Aging’ Month this September. Healthy Aging Month ... attention across the nation on the positive aspects of ... dealing with conditions or side effects from medications that ... Community Outreach Manager for DiaperBuys.com. “This can seem daunting ...
(Date:9/16/2014)... 2014 Banish headaches forever with the ... Cefaly device for chronic migraine relief and treatment. Cefaly ... United States. Until now, US patients would directly place ... Belgium and wait 2-3 weeks for their device to ... States and once prescription and payment is received, the ...
(Date:9/16/2014)... The Fertility Centers of New England ... Bank. The collaboration will give patients access to high-quality ... at the Fertility Centers of New England. , Fairfax ... nation’s largest selection of frozen donor eggs. Access to ... , The Donor is already screened and ...
Breaking Medicine News(10 mins):Health News:Sept. 25 Webinar to Offer Health Plan, Employer Strategies to Control Compounded Medication Costs 2Health News:Mobile EHS Compliance Tools the Focus of Dakota Software’s 2014 Users Conference 2Health News:DiaperBuys Honors ‘Healthy Aging’ Month throughout September 2Health News:DiaperBuys Honors ‘Healthy Aging’ Month throughout September 3Health News:Cefaly Migraine Treatment Device Now Readily Available For Widespread Purchase in United States 2Health News:FCNE Announces Partnership with Fairfax Egg Bank 2
... 6 Prescription pediatric drugs represent,an enormous market, with ... growth is forecast at a modest 3.2%, reaching $43,billion ... share of 11.7%, is,expected to achieve the highest growth ... Kalorama Information,s new report The World Market for,Pediatric Drugs., ...
... Medical Solutions, Inc.,(Rising), a leading medical cost ... Index (PCI) "Top Growth Company" list for ... http://www.newscom.com/cgi-bin/prnh/20080206/AQW030LOGO-b ), (Logo: http://www.newscom.com/cgi-bin/prnh/20080206/AQW030-a ... Inc. ( http://www.entrex.net ), is a,proprietary benchmarking ...
... restatement of Beth Israel Deaconess,Medical Center audit, ... apply the same Sarbanes-Oxley standards used by Massbank ... the board of Beth Israel,Deaconess Medical Center (BIDMC), ... East. Bufferd is also the retired treasurer of,Massachusetts ...
... The Female Health Company,(Amex: FHC ) ... conference call,to discuss its operating results for the ... (EST) on Wednesday, February 13, 2008. The Company ... earlier the same day., Shareholders and other ...
... Medical cost increases for,employers throughout the world ... according to a poll of insurance companies conducted ... The poll also found,that, in a vast majority ... rate of inflation., Nearly three-fourths (71 percent) ...
... A new statewide survey,released today shows that ... tax revenue for programs to prevent kids,from starting ... poll of 500 Virginia voters was released today ... Lung Association and,the Campaign for Tobacco-Free Kids. The ...
Cached Medicine News:Health News:Diabetes, Growth Disorders Drive Sales of Pediatric Hormone Drugs 2Health News:Rising Medical Solutions, Inc. Ranks Fifth on the Private Company Index (PCI) 'Top Growth Companies' List 2Health News:Massbank Board Member Should Use Sarbanes-Oxley Disclosure Rules in Non-Profit Role, Asserts 1199 SEIU 2Health News:The Female Health Company Schedules First Quarter Conference Call for February 13, 2008 2Health News:Medical Cost Increases to Accelerate Worldwide Over Next Five Years, Watson Wyatt Poll Finds 2Health News:Medical Cost Increases to Accelerate Worldwide Over Next Five Years, Watson Wyatt Poll Finds 3Health News:New Poll Shows Virginia Voters Overwhelmingly Favor Funding for Tobacco Prevention 2Health News:New Poll Shows Virginia Voters Overwhelmingly Favor Funding for Tobacco Prevention 3
(Date:9/15/2014)... , Sept. 15, 2014  Patients in today,s ... care more frequently in an outpatient setting versus a ... curve and to ensure that patients continue to receive ... the launch of its new internal medicine residency program. ... more often in office, clinic and even virtual settings. ...
(Date:9/15/2014)... , Sept. 15, 2014  Valeant Pharmaceuticals International, Inc. ... its wholly owned subsidiary, Valeant Pharmaceuticals International, will redeem ... of its 6.75% Senior Notes due 2017, CUSIP Nos. ... 2014 and has mailed an irrevocable notice of redemption ... a copy of the irrevocable notice of redemption with ...
(Date:9/15/2014)... , Sept. 15, 2014 myMatrixx has extended ... Stanos with an expanded role that includes direct ... Dr. Stanos, a nationally recognized physiatrist and pain management ... to rehabilitation and workers, compensation, is Board Certified in ... American Board of Pain Medicine and subspecialty boarded by ...
Breaking Medicine Technology:Kaiser Permanente Hawaii Launches New Internal Medicine Residency Program 2Kaiser Permanente Hawaii Launches New Internal Medicine Residency Program 3Valeant Announces Redemption of All of the Outstanding $500.0 Million Aggregate Principal Amount of its 6.75% Senior Notes due 2017 2myMatrixx Announces Expanded Role for Medical Director Steven P. Stanos, Jr., DO 2
... 2009 Convention -- When Shawnae Jebbia won the Miss USA ... career. She appeared at events throughout the world, worked as ... world unexpectedly changed when she was diagnosed with hearing loss. ... had a difficult time understanding and accepting the sudden hearing ...
... eResearchTechnology, Inc. (ERT), (Nasdaq: ERES ), a leading provider ... medical device and related industries, announced today results for the ... Unless otherwise noted, all comparative numbers refer to changes from ... , Financial highlights for the third quarter of 2009: ...
Cached Medicine Technology:Former Miss USA Shawnae Jebbia Shines with Siemens Pure 2Former Miss USA Shawnae Jebbia Shines with Siemens Pure 3ERT Reports Third Quarter 2009 Results 2ERT Reports Third Quarter 2009 Results 3ERT Reports Third Quarter 2009 Results 4ERT Reports Third Quarter 2009 Results 5ERT Reports Third Quarter 2009 Results 6ERT Reports Third Quarter 2009 Results 7ERT Reports Third Quarter 2009 Results 8ERT Reports Third Quarter 2009 Results 9ERT Reports Third Quarter 2009 Results 10ERT Reports Third Quarter 2009 Results 11ERT Reports Third Quarter 2009 Results 12ERT Reports Third Quarter 2009 Results 13
The Empore 96 well plate vacuum manifold comes complete with waste tray, gasket and shims, may be used as a stand-alone or with 96-well automation....
QIAvac 6S provides all manifold components for processing QIAGEN 8-well strips....
For processing mini spin columns on QIAvac 6S;...
Replacement gaskets for the Empore 96 Well Vacuum Manifold Assembly, insure a tight seal....
Medicine Products: