Navigation Links
FDA Approves Longer Duration Efficacy and Safety for EUFLEXXA®
Date:10/21/2011

PARSIPPANY, N.J., Oct. 21, 2011 /PRNewswire/ -- On Oct. 11, 2011, the FDA approved a labeling supplement for EUFLEXXA (1% sodium hyaluronate) that provides 26-week efficacy data from the FLEXX trial, as well as, 52-week safety data to demonstrate the safety of repeated injection cycles.

The FLEXX trial was a 26-week multicenter, randomized, double-blind study evaluating the safety and efficacy of EUFLEXXA, compared with saline, in patients with painful osteoarthritis of the knee. Patients received three weekly injections of either EUFLEXXA or saline into the target knee. Following the double-blind portion of the trial, patients were offered to receive an additional three weekly injections of EUFLEXXA in a 26-week open-label safety extension. Results from the double-blind portion of the study showed patients treated with EUFLEXXA had a statistically and clinically significant decrease in osteoarthritis knee pain compared to those who received saline control injections as measured by a 50-foot walk test at week 26.

The number of patients reporting adverse events was generally similar between the EUFLEXXA and saline groups. The most common adverse events (>2%) reported in patients treated with EUFLEXXA were: arthralgia, hypertension, back pain, upper respiratory tract infection, diarrhea, injury and cough. In addition, results of the open-label extension demonstrated that repeated injection cycles of EUFLEXXA were well-tolerated up to 52 weeks. In this open-label portion of the study, the most commonly reported adverse events (>2%) were: arthralgia, nasopharyngitis, injury, back pain, joint swelling, upper respiratory tract infection and sinusitis.

"The results further support EUFLEXXA as the first bioengineered, non-avian, effective treatment option that provides osteoarthritis knee pain relief lasting up to six months. The labeling also reflects safety with repeated injection cycles," said Dr. Paul Korner, Senior Vice President,
'/>"/>

SOURCE Ferring Pharmaceuticals Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

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:10/22/2014)... Oct. 22, 2014  With a vision to ... medications, a Global Pharmaceutical and Biotech manufacturer selects ... and turnkey solution to protect their animal health ... Photo - http://photos.prnewswire.com/prnh/20141021/153439 ... serialized and aggregated by the Xyntek and Antares ...
(Date:10/22/2014)... Calif. , Oct. 21, 2014 Influenza will ... flu-associated deaths in the United States ... viruses are thought to spread is from person to person ... Ebola has a serve way of death, but kills much ... Ebola is also done by human fluids including sweat, saliva, ...
(Date:10/22/2014)... Va. and AUSTIN, Texas ... Inc. and PureMHC LLC today announced they have ... develop novel antibody-based immunotherapies designed to target cancers. ... of phosphorylated peptides displayed on the surfaces of ... phosphopeptide tumor targets (PTTs), derived from proteins that ...
Breaking Medicine Technology:Xyntek and Antares Serialization Solution Protects Pets Too! 2WholeHealth Products is proud to be releasing its Influenza A and B combo test, on the heels of the announcing of its phase 2 completion of the Rapid Ebola Test 2Biotech Companies To Co-Discover And Co-Develop Antibodies Targeting Novel Phosphopeptide Tumor Targets 2
... Calif., Aug. 19 Burton Medical, Inc., the leader ... Burton LE-35  to deliver superior illumination, improved reach, and ...  The 35-watt LE-35 provides two to five times more ... improving efficacy and visibility.  This task light provides illuminance ...
... Md., Aug. 19 Novavax, Inc. (Nasdaq: NVAX ... press briefing by U.S. Health and Human Services Secretary Kathleen ... plan to accelerate the development of drugs and vaccines to ... statement of support for the plan,s five key initiatives: ...
Cached Medicine Technology:NOVAVAX Endorses New U.S. Initiatives to Develop Medical Countermeasures 2NOVAVAX Endorses New U.S. Initiatives to Develop Medical Countermeasures 3
(Date:10/22/2014)... HealthDay Reporter , TUESDAY, Oct. 21, 2014 (HealthDay ... be showing a genetic propensity for obesity as toddlers, a ... linked to increased body fat, but the same genes in ... researchers said. At 1 year, kids with these genes ... however, these genes were linked to excessive weight gain, the ...
(Date:10/22/2014)... HealthDay Reporter TUESDAY, Oct. ... in vitro fertilization (IVF) -- the incubation of embryos in ... device inside the vagina, new research suggests. Scientists from ... an INVOcell, might sharply cut costs for pricey IVF procedures ... accessible to those who don,t live near big-city assisted reproduction ...
(Date:10/20/2014)... October 20, 2014 The newly updated ... source of thousands of facts, figures and forecasts on ... 68 medical sector forecast categories the Worldwide Medical ... regional and national views on the worldwide medical market ... The report gives you data for 2010-2019, covering each ...
(Date:10/20/2014)... October 20, 2014 ASCNYC (ascnyc.org) ... that helps New Yorkers living with HIV/AIDS and ... health, housing, recovery and self-sufficiency. Each year, ASCNYC ... local community through their tireless efforts. , ... Shapses , has been selected as this year’s ...
(Date:10/20/2014)... Zereana Jess-Huff, a 34-year-old mother, corporate executive and ... platform to think outside the bra. She doesn’t try to ... raise awareness about women’s other lady parts. , "We have ... the color pink and everybody knows what you’re talking about,” ... it has not been won when it comes to gynecologic ...
Breaking Medicine News(10 mins):Health News:Tall, Heavy 1-Year-Olds May Be at Risk for Obesity Later, Study Finds 2Health News:Experimental Infertility Treatment Seems Effective, Cheaper 2Health News:Experimental Infertility Treatment Seems Effective, Cheaper 3Health News:Experimental Infertility Treatment Seems Effective, Cheaper 4Health News:Worldwide Medical Market Forecasts to 2019 a New Research Report Added to ReportsnReports.com 2Health News:Worldwide Medical Market Forecasts to 2019 a New Research Report Added to ReportsnReports.com 3Health News:Worldwide Medical Market Forecasts to 2019 a New Research Report Added to ReportsnReports.com 4Health News:Savills Studley's Marc Shapses To Be Honored as 2014 "Positive Changemaker" by ASCNYC 2Health News:Savills Studley's Marc Shapses To Be Honored as 2014 "Positive Changemaker" by ASCNYC 3Health News:Ovarian Cancer Survivor Mrs. Maryland Urges Media to Think Outside the Bra 2Health News:Ovarian Cancer Survivor Mrs. Maryland Urges Media to Think Outside the Bra 3
... Ind., May 7 Conseco, Inc. (NYSE: ... regulators and two of,its insurance subsidiaries: Conseco Senior ... Company. The settlement concludes a,multistate market conduct examination ... to long-term care claims practices and,procedures, complaint handling, ...
... May 7 Yesterday H. Con.,Res. 342 was introduced ... opposing the Food and Drug Administration,s (FDA) decision to,restrict ... by women to alleviate the symptoms of menopause. The ... pharmacies in January asking them to,cease and desist with ...
... were missed, more doses taken on time , , WEDNESDAY, May ... are less likely to miss doses when reminded by an ... and announces the number of pills to take and how ... was funded by the National Institute on Aging, was presented ...
... AFL ) announced today that it will webcast its annual Financial,Analysts ... operations in Japan and in the United States as well as ... as,follows:, Wednesday, May 14, 2008 8:00 p.m. ... Daniel P. Amos, Chairman & ...
... May 7 Amneal Pharmaceuticals is pleased,to announce ... Primidone,Tablets (50/250mg), Cyclobenzaprine Tablets (10mg) and Demeclocycline,Tablets (150/300mg) ... products,were filed during 2007 using the FDA,s evolutionary ... months., Demeclocycline HCl Tablets USP, in strengths ...
... NHS Choices ( http://www.nhs.uk ), the new,digital ,front ... Well bundle aimed to,help people stay healthy during ... information, the Live Well Travel health guide,( http://www.nhs.uk/livewell/travelhealth/Pages/Travelhealthhome.aspx ... and provides them,with clinically approved guidance to help ...
Cached Medicine News:Health News:Conseco Reaches Settlement of Multistate Market Conduct Examination 2Health News:Electronic Pillbox Helps Seniors Stick to Drug Regimens 2Health News:Electronic Pillbox Helps Seniors Stick to Drug Regimens 3Health News:Aflac Incorporated to Webcast 2008 Financial Analysts Briefing 2Health News:Aflac Incorporated to Webcast 2008 Financial Analysts Briefing 3Health News:Amneal Pharmaceuticals Receives US FDA Approval for Three Generic Prescription Drugs; Two Using New FDA Electronic Filing Format 2
Multispot HIV-1/HIV-2 is a rapid indirect EIA using recombinant and peptide antigens for simultaneous detection and differentiation of anti-HIV-1 and anti-HIV-2 antibodies in human serum or plasma....
Bio-Rad's Genetic Systems™ HBsAg EIA 3.0 screening and confirmatory assays offer outstanding sensitivity and early detection of HBV infection, helping to meet your testing criteria....
The most compact revolutionary innovation in hematology. 3 Part DIFF + CRP measurement on whole blood....
... Evolis™ is a self contained microplate ... based EIA assays. The system is dedicated ... encountered in todays busy laboratory. The system ... of EIA assays that satisfy their microplate ...
Medicine Products: