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:7/31/2015)... ... July 31, 2015 , ... Precision Aesthetics is New York’s only Thermage ... also the first provider of Exilis non-surgical fat reduction in New York. Due ... attracted a large International clientele. Many patients travel to New York to get ...
(Date:7/31/2015)... ... July 31, 2015 , ... The 2nd annual Ride to Fight On ... on October 3, 2015. The Ride to Fight On is a cycling fundraiser that ... Healthcare, The West Clinic and The University of Tennessee Health Science Center. A health ...
(Date:7/31/2015)... ... 31, 2015 , ... Jacksonville-based drug and alcohol rehabilitation center, ... Center. The medical community, social workers, law enforcement, and government officials are all ... the effort to better understand and combat sex trafficking. Lead by sex trafficking ...
(Date:7/31/2015)... ... July 31, 2015 , ... M3 USA MDLinx.com, source of the ... new Board Exam Courses. , The additions of Gastroenterology, Pulmonology and Allergy/Immunology round ... MDLinx makes preparing for the exam easy and painless. MDLinx offers thousands of ...
(Date:7/31/2015)... ... July 31, 2015 , ... According to an ... gathered to see if they could reach a consensus on the steps that need ... facelifts. Overall, the group reached 90 percent consensus on a series of steps that ...
Breaking Medicine News(10 mins):Health News:West Cancer Center Announces 2nd Annual Ride to Fight On 2Health News:West Cancer Center Announces 2nd Annual Ride to Fight On 3Health News:Lakeview Health Links Sex Trafficking and Addiction in Special Jacksonville Educational Workshop 2Health News:Lakeview Health Links Sex Trafficking and Addiction in Special Jacksonville Educational Workshop 3Health News:MDLinx Offers Three New Board Exam Prep Courses - Gastroenterology, Pulmonology and Allergy/Immunology 2Health News:MDLinx Offers Three New Board Exam Prep Courses - Gastroenterology, Pulmonology and Allergy/Immunology 3Health News:Article on Plastic Surgery Consensus Highlights the Duties of Veteran Plastic Surgeons, says Beverly Hills Physicians 2Health News:Article on Plastic Surgery Consensus Highlights the Duties of Veteran Plastic Surgeons, says Beverly Hills Physicians 3
... ... teach participants unique personal marketing strategies to find employment with a six-point system “The ... is a former talk show host in Columbia at WVOC 560 AM; Kenneth Shuler ... be held for Thomas providing free career counseling services , ...
... ... infection 33 times greater than that reported for our accredited ambulatory surgery centers. ... (PRWEB) June 18, ... Schaefer, Michael Jhung et al (JAMA 2010;303(22):2273 - 2279) correctly places emphasis on the ...
... disorder affecting one in 100 people worldwide. Most cases aren,t ... hallucinations as a teenager or adult. By that time, the ... difficult to treat. In a paper published recently online ... the University of North Carolina at Chapel Hill and Columbia ...
... The National Heart, Lung, and Blood Institute (NHLBI), part of ... to determine if the safety and efficacy of red blood ... been stored. One of the grants supports the first large, ... patients who receive transfusions of red blood cells that have ...
... ... to help women restore energy, passion and healthy hormonal balance. , ... Tampa, FL (Vocus) June 21, 2010 ... supplement for women. Dan-e™ is made of a patent-pending blend of Pro-Hormones and vital ...
... University of Leicester and the University of Ferrara in Italy ... to relieve cancer pain without causing many of the side ... show that 90% of cancer patients experience pain in the ... problem. Currently, the use of drugs like morphine produces side ...
Cached Medicine News:Health News:Columbia Extreme Job Makeover Slated for June 26 2Health News:Columbia Extreme Job Makeover Slated for June 26 3Health News:Infection Rate in Accredited Ambulatory Facilities is Lower than in Hospitals 2Health News:Brain signs of schizophrenia found in babies 2Health News:NHLBI funds research to improve safety of red blood cell transfusions 2Health News:NHLBI funds research to improve safety of red blood cell transfusions 3Health News:NHLBI funds research to improve safety of red blood cell transfusions 4Health News:NHLBI funds research to improve safety of red blood cell transfusions 5Health News:NHLBI funds research to improve safety of red blood cell transfusions 6Health News:NHLBI funds research to improve safety of red blood cell transfusions 7Health News:World Renowned Physician Launches Dan-e™ All-Natural Nutritional Supplement for Women 2Health News:New drugs to relieve cancer pain 2
(Date:7/31/2015)... 31, 2015 Quietly, sedately, Morocco,s ... the domestic pharmaceutical industry is strong, with a well-developed ... high international standards. One place where the ... sub-Saharan Africa: Morocco has quietly become the second largest ... Africa . Indeed, Moroccan pharma companies have been ...
(Date:7/31/2015)... , July 31, 2015 ... Analyzers Market by Product (Bioimpedance Analyzers (BIA), Dual-Energy X-ray ... Hydrostatic Weighing) - Global Analysis & Forecast to 2019", ... was pegged at $911.1 Million 2014 and is estimated ... a CAGR of 9.4% from 2014 to 2019. ...
(Date:7/30/2015)... , July 30, 2015 IRIDEX Corporation ... release its second quarter 2015 financial results after the ... In conjunction with the release, the Company will host ... 5:00 p.m. Eastern Time on Thursday, August ... quarter and other business developments. Interested parties ...
Breaking Medicine Technology:PharmaBoardroom Releases New Morocco Pharmaceuticals Report 2PharmaBoardroom Releases New Morocco Pharmaceuticals Report 3Body Composition Analyzers Market Worth $1,425.7 Million by 2019 2Body Composition Analyzers Market Worth $1,425.7 Million by 2019 3Body Composition Analyzers Market Worth $1,425.7 Million by 2019 4IRIDEX Announces Second Quarter 2015 Conference Call and Release Date 2
... May 25, 2012  ... and Multilab Indústria e Comércio de Produtos Farmacêuticos ... jointly announced that both parties have signed an ... Brazil, "Takeda Brazil"), a wholly-owned subsidiary of Takeda, ...
... 2012  The National Organization for Rare Disorders (NORD) applauds legislation ... the Food and Drug Administration Safety & Innovation Act ... the most comprehensive improvements to public policy for rare disease ... . (Logo: http://photos.prnewswire.com/prnh/20110719/DC37656LOGO-b ) ...
Cached Medicine Technology:Takeda to Acquire Multilab, Enhancing its Business Infrastructure in Brazil 2Takeda to Acquire Multilab, Enhancing its Business Infrastructure in Brazil 3Takeda to Acquire Multilab, Enhancing its Business Infrastructure in Brazil 4NORD Calls Senate Bill Most Important Since Orphan Drug Act 2
... D15/810 diode laser is a versatile and ... soft tissue applications. With excellent hemostatic and ... flexible fiber optic delivery system that allows ... environments alike.,Compact and portable, the Ceralas D15/810 ...
... II is a monoclonal antibody based ... identification of Neisseria gonorrhoeae. The test ... run with no heating or pretreatment. ... viable or fresh cultures. GonoGen&trade II ...
The One-Step Gonorrhea Antigen Tests are qualitative immunoassays for detecting the Gonorrhea Antigen (NGH) in secretory products (swab)....
... thermal keratoplasty (LTK). This procedure was FDA ... reduction of hyperopia from +0.75 to +2.50 diopters ... to 0.75 diopters of astigmatism and refractive stability ... refractive surgery, LTK is not performed in an ...
Medicine Products: