Navigation Links
FDA Approves Strativa Pharmaceuticals' Zuplenz® (ondansetron) Oral Soluble Film
Date:7/2/2010

WOODCLIFF LAKE, N.J., July 2 /PRNewswire/ -- Strativa Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Zuplenz® (ondansetron) oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.  Zuplenz, a unique formulation of ondansetron, is the first oral soluble film approved by the FDA as a prescription medication.

The FDA approval was granted based on clinical study data comparing the bioequivalence of Zuplenz 8 mg to Zofran ODT® (orally dissolving tablet) 8 mg.  The pharmacokinetic results of these studies demonstrated that a single dose of Zuplenz, taken with or without water and under fed and fasting conditions, was comparable to Zofran ODT.

"The FDA approval of Zuplenz marks an important milestone for Strativa as it reinforces our commitment to enhancing prescription products to meet the different needs of patients," said John A. MacPhee, President, Strativa Pharmaceuticals. "Zuplenz offers an innovative and convenient, easy-to-take formulation for patients who have trouble swallowing tablets, while providing the trusted efficacy expected from ondansetron."

Zuplenz uses proprietary PharmFilm® oral soluble film technology from MonoSol Rx to rapidly dissolve on the tongue without the need for water, which can cause additional discomfort for some patients suffering from nausea and vomiting.  Zuplenz will be offered in 4 mg and 8 mg dosage strengths, and is expected to be available in retail pharmacies in the third quarter of 2010.

Nausea and vomiting is a common side effect associated with chemotherapy, radiotherapy, and surgery. Left untreated, nausea and
'/>"/>

SOURCE Strativa Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/28/2015)... , May 28, 2015  Maetrics ( http://maetrics.com ), ... sciences sector, wrapped up a successful conference, "The cost ... Technology industry," today in Zurich . ... ) and its Switzerland -based team, ... the Medical Technology field to an exclusive local audience. ...
(Date:5/28/2015)... 28, 2015  IRIDEX Corporation (NASDAQ: IRIX ) today ... James H. Mackaness is scheduled to present at the ... am PT in Los Angeles . ... accessed on the Event Calendar of the Investors section of ... webcast will be available shortly after the conclusion of the ...
(Date:5/28/2015)... , May 28, 2015 The ... http://www.morcellatorlawsuit2015.com )  in hysterectomies and myomectomies (procedures to remove ... that the FBI is investigating Johnson & Johnson,s ... manufacturer of the devices. According to the report ... 27 th , the FBI is trying to ...
Breaking Medicine Technology:Maetrics Hosts Innovative Medical Cluster Event in Switzerland 2Power Morcellator Attorneys at Bernstein Liebhard LLP Comment on Report That FBI Is Investigating Ethicon Morcellators 2Power Morcellator Attorneys at Bernstein Liebhard LLP Comment on Report That FBI Is Investigating Ethicon Morcellators 3
... Reportlinker.com announces that a new market research report is available in its catalogue: , ... Global Melanoma Therapeutics industry , ... http://www.reportlinker.com/p0197206/Global-Melanoma-Therapeutics-industry.html , , , ... markets for Melanoma Therapeutics in US$ Million. The report provides separate comprehensive analytics for US, ...
... Marcadia Biotech, Inc. and Eli Lilly ... that the companies have signed a development and exclusive ... analogs that may provide greater convenience and ease-of-use than ... hypoglycemia. The program includes MAR531, a glucagon analog that ...
Cached Medicine Technology:Global Melanoma Therapeutics Industry 2Global Melanoma Therapeutics Industry 3Global Melanoma Therapeutics Industry 4Global Melanoma Therapeutics Industry 5Global Melanoma Therapeutics Industry 6Global Melanoma Therapeutics Industry 7Global Melanoma Therapeutics Industry 8Global Melanoma Therapeutics Industry 9Global Melanoma Therapeutics Industry 10Global Melanoma Therapeutics Industry 11Global Melanoma Therapeutics Industry 12Marcadia and Lilly Sign Development, License Agreement for Novel Glucagon Program in Severe Hypoglycemia 2Marcadia and Lilly Sign Development, License Agreement for Novel Glucagon Program in Severe Hypoglycemia 3
(Date:5/28/2015)... Medical Device Cybersecurity Quality Assurance: ... Webinar**, June 23, 2015 — 1:00 p.m. – ... connectivity opens up a wealth of possibilities for ... of potential liabilities. Devices transmit data on the ... be sure the information doesn’t fall into unauthorized ...
(Date:5/28/2015)... CA (PRWEB) May 28, 2015 Cosmetic ... of plastic surgeons and patients alike. You can find ... breast augmentation, and body contouring. Readers can directly connect ... streamlined user experience from the ground up. , The ... is allowing the community to grow and getting it ...
(Date:5/28/2015)... 28, 2015 AMVETS National Executive Director ... Commission on Care established by Congress to examine how ... , Appointed to the commission by Mitch McConnell, majority ... one of only 15 voting members on the panel, ... Accountability Act of 2014. The goal of the commission ...
(Date:5/28/2015)... On Sunday, June 21, 2015, Colorado residents will participate ... the strength, passion and endurance of those facing Alzheimer’s ... this sunrise-to-sunset event symbolizes the challenging journey of those ... funds and awareness to advance the care, support and ... encouraged to create their own experience as they fundraise ...
(Date:5/28/2015)... NJ (PRWEB) May 28, 2015 Three years ... new location for his Shore Vascular & Vein Center! ... the circulatory system. It is his mission to provide ... and respect. , Dr. Jeffrey Gosin is Board ... of the University of Pennsylvania and Jefferson Medical College. He ...
Breaking Medicine News(10 mins):Health News:FDAnews Announces — Medical Device Cybersecurity Quality Assurance: Requirements, Best Practices and Innovative Approaches Webinar, June 23, 2015 2Health News:FDAnews Announces — Medical Device Cybersecurity Quality Assurance: Requirements, Best Practices and Innovative Approaches Webinar, June 23, 2015 3Health News:New York Cosmetic Doctors Now in Cosmetic Town 2Health News:New York Cosmetic Doctors Now in Cosmetic Town 3Health News:AMVETS Executive Director Stewart Hickey Appointed to Congressional Commission on Care 2Health News:Dr. Jeffrey Gosin is Celebrating Three Years at his Somers Point Location! 2Health News:Dr. Jeffrey Gosin is Celebrating Three Years at his Somers Point Location! 3
... found that the frequency with which critically-ill patients developed ... multidisciplinary medical center such as Mayo Clinic compared to ... National Healthcare Safety Network (NHSN). This is good news ... generally strong across the U.S. in intensive care units, ...
... children becoming unconscious after swallowing Aqua Dots beads led to ... the time, it was widely reported that the potentially toxic ... benign but more expensive 1,5-pentanediol (PD) in the manufacture of ... Suchard of the University of California, Irvine confirms these reports, ...
... Nancy Pelosi,issued the following statement today following reports on ... health has been met with great concern., "Senator ... Americans and a,great fighter for America,s children, workers and ... serve him well in this,challenge., "Our thoughts and ...
... spine conference and exhibition draws specialists from across the ... ... Medical Werks, a leading provider of,ceramic components for motion preserving, total disc ... be held in Geneva, Switzerland, May 26-31., The foremost scientific societies ...
... of,America, Inc. today announced that Lindsay Goldberg has ... will use the funds to close,several identified acquisitions ... http://www.newscom.com/cgi-bin/prnh/20071218/CLTU087LOGO ), Ambulatory Services of ... care services in partnership with physicians. In,December 2007, ...
... Foundation,today released the following statement by its founder and ... learned today that Senator Kennedy, a champion for healthcare ... himself facing this,disease. I have no doubt that Senator ... strength that have shaped his lifelong service to this,nation ...
Cached Medicine News:Health News:Intensive care units' prevention of pneumonia in critically-ill patients generally strong 2Health News:Study finds that recalled Aqua Dots did contain poisonous chemical 2Health News:C5 Medical Werks Joins in Sponsoring SpineWeek 2008 in Geneva, Switzerland 2Health News:Ambulatory Services of America, Inc. Announces Investment by Lindsay Goldberg 2
... Made with elastic fabric, these head ... you need to begin testing. Each Electro-Cap ... to the International 10-20 System. When you ... you are using with your head cap ...
... implant was conceived by Arthur C. Perry, ... comprehensive review of the literature on orbital ... back to 1885 (Mules 1885). This review, ... performance of contemporary implants, allowed Perry to ...
... Spheres for Enucleation and Evisceration. ... combine the structure of standard MEDPOR ... mixture. The Bioglass component, mixed throughout ... fibrovascular ingrowth into the MEDPOR PLUS ...
... ICL and the TORIC ICL are posterior ... STAARs proprietary collagen copolymer, the lens rests ... This unique material contains a small amount ... superior optical capability. The lens is gently ...
Medicine Products: