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:3/31/2015)... TUCSON, Ariz. , March 31, 2015  SynCardia ... Investigational Device Exemption (IDE) clinical study on the effective ... The ... with as many as 30 heart failure patients. Patients ... Total Artificial Heart as a bridge to a donor ...
(Date:3/31/2015)... MedSpring Urgent Care is pleased to announce the opening of its ... Upper Greenville. The center – located at 4844 Greenville Avenue – ... Knox - Henderson , its first DFW ... last fall. Additional Dallas metroplex locations are ... and Las Colinas neighborhoods this summer. "We are excited ...
(Date:3/31/2015)... -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD ) ("Galmed"), ... and commercialization of a once-daily, oral therapy for ... today announced financial results for the 12 months ... 2014 Highlights: , Hosted a key opinion ... Rohit Loomba, MD, MHSc., who discussed the topic ...
Breaking Medicine Technology:FDA Approves Investigational Study for New Smaller SynCardia Total Artificial Heart 2FDA Approves Investigational Study for New Smaller SynCardia Total Artificial Heart 3FDA Approves Investigational Study for New Smaller SynCardia Total Artificial Heart 4MedSpring Urgent Care Opens New Upper Greenville Location in Dallas 2Galmed Pharmaceuticals Reports Full Year 2014 Financial Results and Provides Business Update 2Galmed Pharmaceuticals Reports Full Year 2014 Financial Results and Provides Business Update 3Galmed Pharmaceuticals Reports Full Year 2014 Financial Results and Provides Business Update 4Galmed Pharmaceuticals Reports Full Year 2014 Financial Results and Provides Business Update 5Galmed Pharmaceuticals Reports Full Year 2014 Financial Results and Provides Business Update 6Galmed Pharmaceuticals Reports Full Year 2014 Financial Results and Provides Business Update 7Galmed Pharmaceuticals Reports Full Year 2014 Financial Results and Provides Business Update 8
... 12, 2007 /PRNewswire-FirstCall/ --,InB:Biotechnologies, Inc. ("BioTech"), a ... announced strong positive,results in studies of vaccines ... novel, proprietary AIPwLV(TM) vaccine technology. The,studies were ... Molecular,Biotechnology (CMB), the Contract Research Organization led ...
... LUND, Sweden, March 13, 2007--Active Biotech AB,(Stockholm:ACTI.ST) ... a first human micro-dosing trial of an,I-3D ... was to determine the pharmacokinetic,characteristics of the ... healthy volunteers. , The study demonstrated that ...
Cached Medicine Technology:Integrated Biopharma's Proprietary Vaccine Technology Achieves,Strong Positive Results 2Active Biotech's I-3D Micro-dosing Clinical Trial Concluded 2
(Date:3/31/2015)... 2015 Dr. François Blaudeau, the founder ... in a power morcellator lawsuit filed on ... result of metastatic leiomyosarcoma, a rare and aggressive form ... was filed by her husband and is currently pending ... alleges that the power morcellator used during her March ...
(Date:3/31/2015)... 2015 Horizon Blue Cross Blue Shield ... efforts to combat health insurance fraud resulted in $45.4 ... monies recovered and losses avoided -- in 2014. The ... BCBSNJ created its fraud fighting, Special Investigations Unit (SIU) ... have saved members $261 million. , “Our SIU ...
(Date:3/31/2015)... 31, 2015 Altima Technologies, Inc., ... Library for documenting and diagramming data center assets ... , Manufacturer / Device Model, Dell N3000 ... PowerEdge r520, Dell PowerEdge r630, Cisco Catalyst 3850 ... EMC VMAX 100K, VMAX 200K, VMAX 400K , ...
(Date:3/31/2015)... (PRWEB) March 31, 2015 The ... in testosterone lawsuit claims, notes that filings for ... clots and other cardiovascular complications associated with testosterone ... are increasing at a steady pace. The website ... Illinois where the testosterone lawsuits have been centralized, ...
(Date:3/31/2015)... 2015 When SIGVARIS launched the EVERSHEER compression ... product launch to date. Women immediately fell in love with ... another reason to love EVERSHEER with the launch of a ... , Lavender mist pairs perfectly with a variety of navy, ... women looking to add a hint of spring to their ...
Breaking Medicine News(10 mins):Health News:Power Morcellator Lawsuit Filed by Southern Med Law Alleges Wife’s Death Resulted from Cancer Spread via Uterine Morcellation 2Health News:Power Morcellator Lawsuit Filed by Southern Med Law Alleges Wife’s Death Resulted from Cancer Spread via Uterine Morcellation 3Health News:Horizon Blue Cross Blue Shield of New Jersey Saves Members, Health System a Record $45.4 Million through Anti-fraud Efforts 2Health News:Altima Adds More Hardware Devices to its NetZoom™ Visio® Stencils Device Library 2Health News:Testosterone Lawsuit Filings Rise To Over 1,200 In Multidistrict Litigation Pending In Northern Illinois Federal Court Reports The Oliver Law Group 2Health News:Testosterone Lawsuit Filings Rise To Over 1,200 In Multidistrict Litigation Pending In Northern Illinois Federal Court Reports The Oliver Law Group 3Health News:Put Spring in Your Step with SIGVARIS’ Top Selling Sheer Hosiery Compression Therapy Brand 2
... Although Attention Deficit Hyperactivity ... only affecting children, for nearly 9 million adults in ... According to the National Institutes of Mental Health, adults ... a job, remembering or keeping appointments and being productive.To ...
... (NYSE: MED ) announced today that it will release ... March 31, 2009 on Wednesday, April 29, 2009 prior to the ... and web cast to discuss the results on Wednesday, April 29, ... dialing (877) 407-0782 or (201) 689-8567, or can listen via a ...
... April 22 /PRNewswire-FirstCall/ - Hard To Treat Diseases ... Dr. Sanja Pekovic provided updates from a recent ... Anatomische Gesellschaft - Nederlandse Anatomen Vereniging, Antwerpen, 27-30 ... results of recent positive testing being conducted related ...
... April 22 Experts from PAREXEL International ... biopharmaceutical services provider, will present key industry topics during ... Providers Conference, to be held April 28 - 30, ... Florida. Thought leaders from PAREXEL, a sponsor of the ...
... bill clearinghouse is set to help more than 50 million Americans ... debt. IOUSOS™, Powered by GlobeFunder and GlobalTech Collection Services, is ... deal with aged, unpaid patient bills now totaling an estimated $162 ... ...
... has released a new online training program designed to help ... , ... Springville, Utah (PRWEB) April ... the medical transcription industry, has released a new online training ...
Cached Medicine News:Health News:Video: Adults 'Facing' ADHD: ADHD Allies(TM) Offers Unique Online Community for Adults with ADHD on New Facebook(R) Page 2Health News:Video: Adults 'Facing' ADHD: ADHD Allies(TM) Offers Unique Online Community for Adults with ADHD on New Facebook(R) Page 3Health News:Video: Adults 'Facing' ADHD: ADHD Allies(TM) Offers Unique Online Community for Adults with ADHD on New Facebook(R) Page 4Health News:Video: Adults 'Facing' ADHD: ADHD Allies(TM) Offers Unique Online Community for Adults with ADHD on New Facebook(R) Page 5Health News:Medifast, Inc. to Announce First Quarter Fiscal Year 2009 Financial Results on Wednesday, April 29, 2009 2Health News:Hard To Treat Diseases (HTDS) Slavica BioChem Update on Research Activities 2Health News:Hard To Treat Diseases (HTDS) Slavica BioChem Update on Research Activities 3Health News:PAREXEL Experts to Address Partnering Best Practices and Innovative Trial Design at Partnerships With CROs Conference 2Health News:PAREXEL Experts to Address Partnering Best Practices and Innovative Trial Design at Partnerships With CROs Conference 3Health News:PAREXEL Experts to Address Partnering Best Practices and Innovative Trial Design at Partnerships With CROs Conference 4Health News:IOUSOS™ Launches Online Consumer Medical Bill Clearinghouse: New Service Set to Help More than 50 Million Americans and Healthcare Providers 2Health News:IOUSOS™ Launches Online Consumer Medical Bill Clearinghouse: New Service Set to Help More than 50 Million Americans and Healthcare Providers 3Health News:IOUSOS™ Launches Online Consumer Medical Bill Clearinghouse: New Service Set to Help More than 50 Million Americans and Healthcare Providers 4Health News:Career Step Launches New Credential Exam Training Program for Medical Transcription Industry 2
Spacelabs offers an approach that allows your telemetry and step-down units to configure systems to meet their telemetry requirements. Our modular telemetry system data are integrated into the depart...
ISI Alumi-Hand is the safe, sterile, ready-to-use ,surgical hand immobilizer....
The Tele-Pro WEP-4200 Telemetry System is an 8-Patient Stand Alone System. Offering capabilities such as arrhythmia analysis, trends and full disclosure, the Tele-Pro is a system to help hospitals to...
ISI Self-Supporting Arm Table offers the easy accessibility for surgeons, technicians and equipment during upper extremity surgeries....
Medicine Products: