Navigation Links
FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment for Routine Prophylaxis in Children with Hemophilia A
Date:10/10/2008

ilia patients. Joint structural outcomes and functioning were measured at 6 years of age by radiography, magnetic resonance imaging (MRI) and physical exams.

"The value for prophylaxis for hemophilia A patients has been understood for many years, but until today we have not had the combination of clinical evidence, pharmaceutical indication and the alignment of healthcare professionals, patients and regulators needed to ensure this treatment option is available," said Val Bias, CEO, National Hemophilia Foundation. "Bayer HealthCare's pursuit of this approval shows leadership and commitment to providing the scientific evidence that proves the benefits of prophylactic use for joint health in pediatric hemophilia patients."

This U.S. FDA approval may positively affect the prophylactic use of Kogenate FS in certain developing markets, including countries in Asia and South and Central America, where the product is approved based on the U.S. label.

"Today's announcement is a milestone in Bayer HealthCare's continuing commitment to advancing the science and treatment for the hemophilia community," said Paul Bedard, Vice President, General Manager, Hematology Business Unit, Bayer HealthCare. "From the beginning, our goal in pursuing this indication was to provide treatment options that would reduce bleeding episodes and protect the joint health of children with hemophilia A, which are the everyday concerns of patients."

About Kogenate(R) FS

Kogenate(R) FS, Antihemophilic Factor (Recombinant), is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) with hemophilia A. Kogenate FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage. The most serious adverse reactions are systemic hypersensitivity reactions i
'/>"/>

SOURCE Bayer HealthCare
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. F.D.A. Approves SANCUSO(R), the First and Only Patch for Preventing Nausea and Vomiting in Cancer Patients Undergoing Chemotherapy
2. FDA Approves First Hepatitis B Viral Load Test
3. U.S. FDA Approves Requip(R) XL(TM), the First and Only Oral Once-Daily Non-Ergot Dopamine Agonist for Parkinsons Disease
4. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
5. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
6. 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
7. 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)
8. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
9. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
10. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
11. 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
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/20/2014)... 2014 Norgine B.V. today announced ... volume bowel preparation, NER1006, presented at the 79 th ... Gastroenterology (ACG), Philadelphia, PA , has ... and co-primary endpoint of cleansing success. The study demonstrated ... ® in screening colonoscopy patients. [1] ...
(Date:10/19/2014)... -- Henry Schein, Inc. (NASDAQ: HSIC ), the ... to office-based dental, animal health and medical practitioners, announced ... Inc., a leading full-service provider of dental consumables, implants ... into Japan , the world,s 2 ... the number of countries in which the Company operates. ...
(Date:10/17/2014)... , Oct. 17, 2014  Training market researchers ... critical success factor in today,s highly competitive global ... research organizations that effectively and efficiently produce high ... service area. Effective training programs ... earn recognition from internal clients by developing analysts ...
Breaking Medicine Technology:Positive Results from Phase II Data Show NER1006 Achieves High Quality Bowel Cleansing Efficacy 2Henry Schein Enters Japan With Investment in Iwase Dental Supply 2Henry Schein Enters Japan With Investment in Iwase Dental Supply 3Henry Schein Enters Japan With Investment in Iwase Dental Supply 4Henry Schein Enters Japan With Investment in Iwase Dental Supply 5Effective Training Programs for Market Research Groups can Boost Overall Organizational Success 2
... , MALVERN, ... a privately held biopharmaceutical company, and Cephalon, Inc. (Nasdaq: ... trial for CINQUIL(TM) (reslizumab) as a treatment for pediatric eosinophilic ... in the co-primary endpoints of changes in esophageal eosinophil levels ...
... , WAPPINGERS ... Medical, in alliance with the American Academy of Pediatrics (AAP), ... with Laerdal,s SimNewB (TM) neonatal patient simulator. SimNewB is designed ... to facilitate training for treatment of other critical medical conditions ...
Cached Medicine Technology:Ception Therapeutics and Cephalon Provide Initial Results of a Phase IIb/III Study of CINQUIL in Pediatric Eosinophilic Esophagitis 2Ception Therapeutics and Cephalon Provide Initial Results of a Phase IIb/III Study of CINQUIL in Pediatric Eosinophilic Esophagitis 3Ception Therapeutics and Cephalon Provide Initial Results of a Phase IIb/III Study of CINQUIL in Pediatric Eosinophilic Esophagitis 4Ception Therapeutics and Cephalon Provide Initial Results of a Phase IIb/III Study of CINQUIL in Pediatric Eosinophilic Esophagitis 5Neonatal Scenarios Developed in Partnership with the American Academy of Pediatrics (AAP), Utilize the NRP Curriculum to Advance Newborn Care 2Neonatal Scenarios Developed in Partnership with the American Academy of Pediatrics (AAP), Utilize the NRP Curriculum to Advance Newborn Care 3
(Date:10/20/2014)... 20, 2014 AttorneyOne.com, a recognized authority on ... from the FDA on Sit and Slim II . ... to purchase or use Sit and Slim II because it ... is promoted as weight loss product on various websites and ... market in 2010 for safety reasons, can significantly increase blood ...
(Date:10/20/2014)... October 20, 2014 Rockynol Retirement ... Center on Oct. 14. The $11 million project will ... and a cooked-to-order kitchen with full-service restaurant style dining. ... choice for first class Assisted Living apartments,” said Kara ... deserve the highest quality of care and this investment ...
(Date:10/20/2014)... (PRWEB) October 20, 2014 Based ... are the only imaging assays capable of determining ... single test.  With these three dimensions of high-resolution ... to detect the widest range of disease-causing genetic ... missed by other genomic tools, including today’s advanced ...
(Date:10/20/2014)... Final Cut Pro X Plugin developers from Pixel ... for FCPX filmmakers . , “Fun, cool, and simple ... theme” Says Christina Austin, CEO of Pixel Film Studios. “It ... Citrus comes with all the tools needed for a ... for added style, a title screen for an introduction, two ...
(Date:10/20/2014)... 2014 It’s hard to imagine what it’s ... vulnerable children around the world, it’s a reality. And while ... children are forced to walk barefoot on rocky terrain or ... play with their friends. , Buckner International's Shoes ... Radio in October to encourage support for Air1 and ...
Breaking Medicine News(10 mins):Health News:FDA Advises Not to Use Sit and Slim II: AttorneyOne Monitors and Keeps Consumers Informed 2Health News:Rockynol Retirement Community Expands Assisted Living Center 2Health News:KromaTiD Launches Genome Screening and Discovery Services 2Health News:KromaTiD Launches Genome Screening and Discovery Services 3Health News:Today Pixel Film Studios Announced the Release of the Citrus theme for Final Cut Pro X 2Health News:Buckner Shoes for Orphan Souls® Garners Support from Air1 Radio 2Health News:Buckner Shoes for Orphan Souls® Garners Support from Air1 Radio 3
... Paragon Medsystems unveiled their new corporate identity at ... Effective immediately, the company name will be California MedTech.The ... providing turnkey development and manufacturing services to the medical ... focus on the medtech sector, as well as our ...
... Hepatocellular carcinoma (HCC) is a highly aggressive form of ... cancers worldwide. Devanand Sarkar and colleagues, at Virginia Commonwealth ... gene that is expressed at high levels in human ... HCC progression. They therefore suggest that targeting this gene ...
... the two might be genetic, researchers say , , MONDAY, Feb. ... melanoma are twice as likely to develop Parkinson,s disease, a ... are not clear, other studies have shown that people with ... "For people with a family member with melanoma, they may ...
... patients who undergo surgery at teaching-intensive hospitals have ... these better survival rates apparently occur in white ... in surgical outcomes for patients in teaching-intensive hospitals ... from other studies," said study leader Jeffrey H. ...
... improved expertise after surgery, but reasons unclear, study finds ... are less likely to die of post-surgery complications at ... doesn,t apply to black patients, a U.S. study. finds. ... at The Children,s Hospital of Philadelphia and the University ...
... technological breakthroughsCLEVELAND, Feb. 16 NorTech, in partnership ... to announce the winners of its annual Innovation ... Northeast Ohio innovators who are impacting the lives ... world. This year, a distinguished panel of judges ...
Cached Medicine News:Health News:Paragon Medsystems Becomes California MedTech 2Health News:Family History of Melanoma Doubles Parkinson's Risk 2Health News:White Patients Benefit More Than Blacks in Surviving Surgical Complications at Teaching Hospitals 2Health News:White Patients Benefit More Than Blacks in Surviving Surgical Complications at Teaching Hospitals 3Health News:Teaching Hospitals' Post-Op Gains Not Extended to Blacks 2Health News:NorTech, Crain's Cleveland Business Honor 2009 Innovation Award Winners 2Health News:NorTech, Crain's Cleveland Business Honor 2009 Innovation Award Winners 3Health News:NorTech, Crain's Cleveland Business Honor 2009 Innovation Award Winners 4Health News:NorTech, Crain's Cleveland Business Honor 2009 Innovation Award Winners 5
... The compact Allegra X-22 Series is up to 10 ... a library of 11 rotors, the Allegra X-22 Series ... Features: Only 18 inches / 46 cm ... 22,065 x g 3 different ways to Spin ...
... Optimal for Subcellular Fractionation, ... x g (30,000 rpm) with ... from 0.25 up to 85 ... 2° C to 40° C ...
... to accommodate over 55 centrifuge tubes, bottles, ... labile samples. Incorporating the latest technology, these ... quick cooling from 22 C to 4 ... brushless motor, low pitch 62 dBA quiet ...
Inquire...
Medicine Products: