Navigation Links
FDA Approves Product to Prevent Bleeding in People With Rare Genetic Defect
Date:2/17/2011

SILVER SPRING, Md., Feb. 17, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Patients with congenital Factor XIII deficiency don't make enough Factor XIII, a substance that circulates in the blood and is important for normal clotting. Without treatment, people with the condition are at risk for life-threatening bleeding.

Congenital Factor XIII deficiency is rare and affects 1 out of every 3 million to 5 million people in the United States. The deficiency may lead to soft tissue bruising, mucosal bleeding and fatal intracranial bleeding. Newborns with Factor XIII deficiency may have umbilical cord bleeding.

"This product helps fill an important need," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research.

Corifact received orphan-drug designation by the FDA because it is intended for use in a rare disease or condition. It was approved for marketing under the FDA's accelerated approval regulations that require an on-going study to demonstrate that patients actually receive the clinical benefit predicted by the data obtained so far.

The FDA approved Corifact based on results of a clinical study of 14 people, including children, with congenital Factor XIII deficiency. The most common side effects observed were hypersensitivity reactions (allergy, rash, pruritus, and erythema), chills, fever, arthralgia, headache, elevated thrombin-antithrombin levels, and an increase in liver (hepatic) enzymes.

Corifact is made from the pooled plasma of healthy donors. People receiving Corifact may develop antibodies against Factor XIII that may make the product ineffective. It potentially can cause adverse
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. FDA Approves First 3-D Mammography Imaging System
2. FDA Approves 1st Pacemaker Designed to Work Safely During Some MRI Exams
3. FDA Approves Hologics Makena™ (Formerly Referred to as Gestiva™) Pharmaceutical
4. FDA Approves Drug to Reduce Risk of Preterm Birth in At-Risk Pregnant Women
5. FDA Approves Makena™, the First and Only Treatment to Reduce the Risk of Preterm Birth in Women With a Singleton Pregnancy Who Have a History of Singleton Spontaneous Preterm Birth
6. FDA Approves Viibryd to Treat Major Depressive Disorder
7. FDA Approves Head Lice Treatment for Children and Adults
8. FDA Approves Opioid Analgesic to Help Cancer Patients Manage Pain
9. VIDEO from Endo Pharmaceuticals Available on thenewsmarket.com: FDA Approves New Treatment for Low Testosterone
10. FDA Approves New Dosage Strength for INTELENCE®
11. U.S. FDA Approves Second Bayer Oral Contraceptive That Also Raises Folate Levels
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/3/2015)... A global continuing medical education ... thyroid disorders in Central and South-East Asia ... major conference dedicated to these diseases.      ... , Manage Hypertension Online and Manage ... EXCEMED - combine the world,s top expertise ...
(Date:7/3/2015)... A global continuing medical education ... thyroid disorders in Latin America ... dedicated to these diseases.      (Logo: http://photos.prnewswire.com/prnh/20150630/227033) ... Manage Hypertension Online and Manage Thyroid Online ... - combine the world,s top expertise with dynamic ...
(Date:7/3/2015)... STOCKHOLM , July 3, 2015 ... agreement with Broda Technologies Co., Ltd., operating in both ... use the company,s proprietary IntelliGel ® supramolecular hydrogel ... under development and other ophthalmic therapies. The Broda technology ... polymer solution is a free-forming liquid and with low ...
Breaking Medicine Technology:Combating Three Major Chronic Diseases in Central and South-East Asia With Medical Education 2Combating Three Major Chronic Diseases in Latin America With Medical Education 2Redwood Pharma Licenses Novel Hydrogel Drug Delivery Technology From Broda Technologies 2
... , , , , FRAZER, Pa., Jan. ... that effective February 5, 2010, Robert P. Roche, Jr., Executive ... with the company to pursue other longstanding interests. During ... and marketing organization into a global business that exceeded $2 ...
... , SOUTH SAN FRANCISCO, Dec. 31 ... was unable to satisfy the closing conditions set forth in ... among Anesiva, Arca Acquisition Corporation, a wholly-owned subsidiary of Anesiva, ... and IX only of the agreement, each of the Arcion ...
Cached Medicine Technology:Cephalon Executive Vice President of Worldwide Pharmaceutical Operations Robert Roche to Resign Position 2Cephalon Executive Vice President of Worldwide Pharmaceutical Operations Robert Roche to Resign Position 3Cephalon Executive Vice President of Worldwide Pharmaceutical Operations Robert Roche to Resign Position 4Anesiva Announces Merger With Arcion Therapeutics Will Not be Completed 2
(Date:7/4/2015)... ... July 05, 2015 , ... Dating a real millionaire online ... best online millionaire dating service and strives to remove the worries from meeting partners. ... millionaire dating app of 2015 and readers have responded with excitement. ...
(Date:7/4/2015)... ... July 04, 2015 , ... Tyler Boden, Project Developer ... sales expertise from the North American Board of Certified Energy Practitioners (NABCEP®), and ... highly respected and well established national certification organization for renewable energy professionals. Designation ...
(Date:7/3/2015)... ... July 03, 2015 , ... ... its 2015 Annual Conference , the premiere continuing education and networking ... Orlando at SeaWorld in Orlando, Florida. Speakers include the leading rheumatology experts ...
(Date:7/3/2015)... , ... July 03, 2015 , ... ... to healthcare providers, has been retained to lead a national chief nursing ... the top-ranked executive search firms in the healthcare industry, B. E. Smith has ...
(Date:7/3/2015)... ... July 03, 2015 , ... Jennifer Renee Hanes, DO is the new ... the largest network of independent freestanding emergency rooms in the United States. , “We ... Sienna Plantation facility,” said Executive Medical Director of First Choice Emergency Room, Dr. James ...
Breaking Medicine News(10 mins):Health News:MillionaireMatchapp.com Publishes the Best Millionaire Dating App and Official Dating Site Reviews 2015 2Health News:Local Solar Professional Earns Industry's Most Prestigious Certification 2Health News:Local Solar Professional Earns Industry's Most Prestigious Certification 3Health News:RNS Announces Sessions and Speaker Lineup for the 2015 Annual Conference of the Rheumatology Nurses Society 2Health News:RNS Announces Sessions and Speaker Lineup for the 2015 Annual Conference of the Rheumatology Nurses Society 3Health News:Jane Phillips Medical Center Retains B. E. Smith to Recruit New Chief Nursing Officer 2Health News:Jane Phillips Medical Center Retains B. E. Smith to Recruit New Chief Nursing Officer 3Health News:Dr. Jennifer Renee Hanes Named by First Choice Emergency Room as Medical Director of Missouri City, TX Facility 2Health News:Dr. Jennifer Renee Hanes Named by First Choice Emergency Room as Medical Director of Missouri City, TX Facility 3
... (August 15, 2011) Autism Speaks, the world,s largest autism ... the largest known study of younger siblings of children who ... study, based on data from the Autism Speaks High Risk ... the UC Davis MIND Institute, was published online today in ...
... are at an increased risk of dying due to ... BioMed Central,s open access journal Arthritis Research & ... for people with RA is due to disease-related inflammation ... general population. Treatment of arthritis with disease modifying antirheumatic ...
... Aug. 13 (HealthDay News) -- Although many children anxiously anticipate ... about the transition than others. Children who are excessively ... larger problem, an expert says. "Even though most children ... quite happy and adjust to the new school within two ...
... Standing water is a breeding ground for mosquitoes that can ... many urban families don,t take simple steps such as dumping ... Last summer, researchers polled 242 urban residents to find out ... risks posed by standing water, a mosquito breeding ground. Researchers ...
... disease who go to a neurologist for their care are more ... nursing home and less likely to break a hip than people ... published in the August 10, 2011, online issue of Neurology, ... The study also found that women and minorities were ...
... News) -- More doctors are performing weight-loss surgery today, ... study finds. Researchers analyzing trends in bariatric surgery ... as adjustable gastric banding, has led to a greater ... , "We,ve identified a national trend ...
Cached Medicine News:Health News:Risk of autism among younger siblings of a child with autism much greater than previously reported 2Health News:Planning Ahead Can Reduce Back-to-School Stress 2Health News:Get Rid of Standing Water to Protect From Mosquitoes 2Health News:Study suggests seeing a neurologist helps people with Parkinson's live longer 2Health News:Weight-Loss Surgery Gains More Practitioners 2
A distal femoral nail providing high purchase in osteoporotic metaphyseal bone and two distal locking options: one spiral blade plus one locking screw or two locking screws....
... neurodiagnostic for basic and advanced ... a large 12.1" XGA (1024 ... and the latest in technology ... speed, advanced NCS capabilities, advanced ...
... potential vision tester measures retinal acuity in ... Potential vision testing requires two related tools, ... (formerly known as the Illuminated Near Card) ... a pinhole disc and hinged lens). ...
The ACCU-Beam® line of Surgical Microscope Accessories includes digital camera adaptors, beam splitters, objective lenses, fiber optic cables, and fiberoptic retrofits....
Medicine Products: