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:7/24/2014)... 24, 2014 Lpath, Inc. (NASDAQ: ... lipid-targeted therapeutics, reported interim results in a Phase ... investigated as a treatment for metastatic renal cell ... least one therapy involving a VEGF inhibitor (e.g., ... mTOR inhibitor (e.g., Afinitor®/everolimus), with a maximum of ...
(Date:7/24/2014)... N.J., July 24, 2014 , Revenues ... year , Adjusted diluted EPS from continuing operations of ... EPS from continuing operations of $0.92, 7% below prior year ... versus prior year , Full year 2014 revenues now ... to 4% previously , Full year 2014 adjusted diluted ...
(Date:7/24/2014)... HIGHLIGHTS:Q2 2014 Results (all percentage changes ... sales increased 3% to $701 million.  Sales grew organically by ... percentage point to sales growth. , By business unit, ... and 1% in SAFC Commercial. , Reported diluted EPS ... of 13%.  Adjusted diluted EPS in Q2 2014 was also ...
Breaking Medicine Technology:Lpath Reports Interim Data From Phase 2a Study for Anti-Cancer Drug, ASONEP 2Lpath Reports Interim Data From Phase 2a Study for Anti-Cancer Drug, ASONEP 3Lpath Reports Interim Data From Phase 2a Study for Anti-Cancer Drug, ASONEP 4Quest Diagnostics Reports Second Quarter 2014 Financial Results 2Quest Diagnostics Reports Second Quarter 2014 Financial Results 3Quest Diagnostics Reports Second Quarter 2014 Financial Results 4Quest Diagnostics Reports Second Quarter 2014 Financial Results 5Quest Diagnostics Reports Second Quarter 2014 Financial Results 6Quest Diagnostics Reports Second Quarter 2014 Financial Results 7Quest Diagnostics Reports Second Quarter 2014 Financial Results 8Quest Diagnostics Reports Second Quarter 2014 Financial Results 9Quest Diagnostics Reports Second Quarter 2014 Financial Results 10Quest Diagnostics Reports Second Quarter 2014 Financial Results 11Quest Diagnostics Reports Second Quarter 2014 Financial Results 12Quest Diagnostics Reports Second Quarter 2014 Financial Results 13Quest Diagnostics Reports Second Quarter 2014 Financial Results 14Quest Diagnostics Reports Second Quarter 2014 Financial Results 15Quest Diagnostics Reports Second Quarter 2014 Financial Results 16Quest Diagnostics Reports Second Quarter 2014 Financial Results 17Quest Diagnostics Reports Second Quarter 2014 Financial Results 18Quest Diagnostics Reports Second Quarter 2014 Financial Results 19Quest Diagnostics Reports Second Quarter 2014 Financial Results 20Quest Diagnostics Reports Second Quarter 2014 Financial Results 21Quest Diagnostics Reports Second Quarter 2014 Financial Results 22Sigma-Aldrich (NASDAQ - SIAL) Reports Record Q2 2014 Results With Sales Of $701 Million And Diluted EPS Of $1.11. Raises Lower-End Of Full-Year 2014 Adjusted Diluted EPS Guidance To A New Range Of $4.32 To $4.40. 2Sigma-Aldrich (NASDAQ - SIAL) Reports Record Q2 2014 Results With Sales Of $701 Million And Diluted EPS Of $1.11. Raises Lower-End Of Full-Year 2014 Adjusted Diluted EPS Guidance To A New Range Of $4.32 To $4.40. 3Sigma-Aldrich (NASDAQ - SIAL) Reports Record Q2 2014 Results With Sales Of $701 Million And Diluted EPS Of $1.11. Raises Lower-End Of Full-Year 2014 Adjusted Diluted EPS Guidance To A New Range Of $4.32 To $4.40. 4Sigma-Aldrich (NASDAQ - SIAL) Reports Record Q2 2014 Results With Sales Of $701 Million And Diluted EPS Of $1.11. Raises Lower-End Of Full-Year 2014 Adjusted Diluted EPS Guidance To A New Range Of $4.32 To $4.40. 5Sigma-Aldrich (NASDAQ - SIAL) Reports Record Q2 2014 Results With Sales Of $701 Million And Diluted EPS Of $1.11. Raises Lower-End Of Full-Year 2014 Adjusted Diluted EPS Guidance To A New Range Of $4.32 To $4.40. 6Sigma-Aldrich (NASDAQ - SIAL) Reports Record Q2 2014 Results With Sales Of $701 Million And Diluted EPS Of $1.11. Raises Lower-End Of Full-Year 2014 Adjusted Diluted EPS Guidance To A New Range Of $4.32 To $4.40. 7Sigma-Aldrich (NASDAQ - SIAL) Reports Record Q2 2014 Results With Sales Of $701 Million And Diluted EPS Of $1.11. Raises Lower-End Of Full-Year 2014 Adjusted Diluted EPS Guidance To A New Range Of $4.32 To $4.40. 8Sigma-Aldrich (NASDAQ - SIAL) Reports Record Q2 2014 Results With Sales Of $701 Million And Diluted EPS Of $1.11. Raises Lower-End Of Full-Year 2014 Adjusted Diluted EPS Guidance To A New Range Of $4.32 To $4.40. 9Sigma-Aldrich (NASDAQ - SIAL) Reports Record Q2 2014 Results With Sales Of $701 Million And Diluted EPS Of $1.11. Raises Lower-End Of Full-Year 2014 Adjusted Diluted EPS Guidance To A New Range Of $4.32 To $4.40. 10Sigma-Aldrich (NASDAQ - SIAL) Reports Record Q2 2014 Results With Sales Of $701 Million And Diluted EPS Of $1.11. Raises Lower-End Of Full-Year 2014 Adjusted Diluted EPS Guidance To A New Range Of $4.32 To $4.40. 11Sigma-Aldrich (NASDAQ - SIAL) Reports Record Q2 2014 Results With Sales Of $701 Million And Diluted EPS Of $1.11. Raises Lower-End Of Full-Year 2014 Adjusted Diluted EPS Guidance To A New Range Of $4.32 To $4.40. 12
... CAMPBELL, Calif., Oct. 14, 2011 EMKinetics, Inc. ... System pivotal trial for patients suffering ... trial will be conducted at 10-15 US centers. ... follow the completion of the study.   EMKinetics, ...
... The Better Hearing Institute (BHI) is warning ... one-size-fits-all hearing aids instead of consulting a hearing healthcare ... serious underlying medical problem. All 50 states require that ... hearing aids. BHI also points out that ...
Cached Medicine Technology:EMKinetics Announces Start of Pivotal Trial for the TranStim™ Transdermal Neuromodulation System 2Better Hearing Institute Warns on Do-It-Yourself Hearing Care 2Better Hearing Institute Warns on Do-It-Yourself Hearing Care 3
(Date:7/24/2014)... July 23, 2014 (HealthDay News) -- Even though its use ... known as Tylenol -- does not help treat lower back ... researchers found the drug was no more effective than a ... lower back pain. Besides showing no effect in easing ... in improving sleep woes tied to back pain, nor did ...
(Date:7/24/2014)... July 24, 2014Malcolm K. Brenner, MD, PhD, Baylor College ... basic and clinical research toward understanding how tumors are ... system, and developing genetically modified T cells that can ... and leadership in the field, Dr. Brenner is the ... Therapy , a peer-reviewed journal from Mary Ann Liebert, ...
(Date:7/24/2014)... 2014 Becker's Hospital Review has published ... Health Systems With Great Oncology Programs." Organizations on this ... quality patient care, cancer outcomes and research. , The ... based on rankings and awards they have received from ... considered as part of the criteria for inclusion on ...
(Date:7/24/2014)... 24, 2014 "North America Spinal ... data on the North America Spinal Surgery market. ... dollars, and volume (in units) and average price ... Fusion, Vertebral Compression Fracture Repair Devices and Spinal ... America Spinal Surgery Market:,     Medtronic, ...
(Date:7/24/2014)... 2014. LSE Health and the European Heart Academy ... are pleased to announce the launch of a ... the field of cardiovascular sciences. , The MSc ... Sciences aims to equip cardiovascular specialists with the ... to take on advisory, management or leadership roles ...
Breaking Medicine News(10 mins):Health News:Acetaminophen May Not Help Against Back Pain, Study Contends 2Health News:Acetaminophen May Not Help Against Back Pain, Study Contends 3Health News:Malcolm K. Brenner receives Pioneer Award for advances in gene-modified T cells targeting cancer 2Health News:100 Hospitals, Health Systems With Great Oncology Programs 2Health News:100 Hospitals, Health Systems With Great Oncology Programs 3Health News:100 Hospitals, Health Systems With Great Oncology Programs 4Health News:Spinal Surgery Market in North America Forecast to 2020 New Report Available at ReportsnReports.com 2Health News:Spinal Surgery Market in North America Forecast to 2020 New Report Available at ReportsnReports.com 3Health News:Spinal Surgery Market in North America Forecast to 2020 New Report Available at ReportsnReports.com 4Health News:LSE and ESC announce the launch of a new executive-style MSc 2
... cabinet, may help in easing out prostate problem, according to ... known to help in the prevention of arthritic inflammations, heart ... The researchers say that now it may help solve some ... enlarged prostates. ,It may help reduce the urinary ...
... view of The Sterling Council, of levying ?1 a week for ... refuses to buy. The complainant, Mrs. C, has not minced words ... the society, and truly a mockery of the free care provided ... emergency care system in her home in 2002. This allowed emergency ...
... of the University of Sao Paulo Medical School in Brazil ... getting the best care in case of chronic coronary artery ... to be published in the September edition of the Journal ... to receive their physician-recommended treatment showed a significantly lower incidence ...
... A British tourist in Hong Kong is suspected of having the ... been named and was admitted to a Hog Kong hospital// after ... man came to the country on April 4 and was admitted ... Chinese origin and underwent intestinal surgery earlier. Hong Kong health department ...
... A $500,000 television and radio ad campaign blaming GOP ... prescription drug program has been launched by the// Association ... ,The ad campaign accusing the lawmakers for blocking provisions ... companies for the best prescription cost has been targeted ...
... techniques and concussions among high school athletes found that ... of// concussion. ,In the current ... Medicine in Philadelphia and co-author Dr. Tracey Covassin of ... directors of athletics from Pennsylvania and New Jersey high ...
Cached Medicine News:Health News:Patient’s Individual Cardiologist Best Judge For Deciding Appropriate Treatment In Chronic Coronary Artery Diseas 2Health News:Patient’s Individual Cardiologist Best Judge For Deciding Appropriate Treatment In Chronic Coronary Artery Diseas 3Health News:Ad Campaign Targeting Republicans On Medicare Prescription Drug Program 2Health News:Proper Fitting Of Football Helmets Essential To Prevent Concussion 2
... EX.P.R.T. Release Technology essentially eliminates premature ... Unique anatomically designed tapered stent for ... 0.014 Rapid Exchange catheter with 6 ... atraumatic tip,, Radiopaque marker on catheter ...
... blood hematology control manufactured specifically for the ... the Coulter AcT5diff instruments. The composition of ... differential, positioning the populations within the limitations ... product offers 105-day closed-vial stability and 14-day ...
... a whole blood control for evaluating the ... measure automated blood cell counts in patient ... RBC and WBC values for the Abbott ... LH750/LH 755 (levels 2 and 3 only) ...
... is a gene expression ... the risk of metastasis ... It is based on ... the Netherlands Cancer Institute ...
Medicine Products: