Navigation Links
FDA Approves Ferriprox to Treat Patients with Excess Iron in the Body
Date:10/14/2011

the level of a liver enzyme that may be indicative of tissue or liver damage at unsafe amounts.

The most serious side effect seen in about two percent of patients treated with Ferriprox was the development of agranulocytosis, a serious and potentially life-threatening reduction in the number of granulocytes (a type of white blood cell that fights infection).

The therapy is being approved under the FDA's accelerated approval program, designed to provide patients with earlier access to promising new drugs followed by further studies to confirm the drug's clinical benefit.

The accelerated approval program allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on an endpoint that is reasonably likely to predict a clinical benefit to patients, or on an effect on a clinical endpoint other than survival or irreversible morbidity (illness).

ApoPharma has agreed to several post-marketing requirement and commitments. One commitment includes further study of the use of Ferriprox in patients with sickle cell disease who have transfusional iron overload.

Earlier this year, the U.S. Department of Health and Human Services (HHS) launched the Sickle Cell Disease (SCD) Initiative bringing together HHS agencies to enhance the quality and quantity of SCD data, develop best practice guidelines and quality of care metrics, improve health care delivery and coordination of care for patients with SCD, facilitate approval of new medical products, and expand research on SCD.  The post-marketing requirement for further study of Ferriprox aligns with the goals of the SCD Initiative.

Ferriprox is marketed by ApoPharma Inc. of Toronto.

For more information:

FDA: Office of Hematology and Oncology Products
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091745.htm

FDA: Spotlight o
'/>"/>

SOURCE U.S. Food and Drug Administration
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:10/25/2014)... DUBLIN , Oct. 24, 2014 ... "Dental Equipment Market Current Trends, Opportunities - Global ... In this report, the global dental equipment ... geography. The dental systems and equipment market is expected ... equipment market during the forecast period (2014 to 2019). ...
(Date:10/25/2014)... , Oct. 24, 2014  America,s future engineers ... robotic competition at the  Medical Design and Manufacturing ... 29-30 th at the Minneapolis ... local student built robots from the "For Inspiration ... FIRST students and mentors will offer information to ...
(Date:10/25/2014)... , October 24, 2014 ... the addition of the "Global and Chinese ... their offering.      (Logo: http://photos.prnewswire.com/prnh/20130307/600769) , ... Report 2014 is a professional and in-depth study ... industry with a focus on the Chinese situation. ...
Breaking Medicine Technology:Dental Equipment Market Current Trends, Opportunities - Global Forecast to 2019 2Dental Equipment Market Current Trends, Opportunities - Global Forecast to 2019 3Local robotics teams compete - a "FIRST" at next week's MD&M Minneapolis- October 29-30th at the Minneapolis Convention Center 2Local robotics teams compete - a "FIRST" at next week's MD&M Minneapolis- October 29-30th at the Minneapolis Convention Center 3Global and Chinese Hemodialysis Concentrates Industry Report 2014 2Global and Chinese Hemodialysis Concentrates Industry Report 2014 3
... Quark siRNAs Examined Alone and in Combination ... Quark Pharmaceuticals, Inc., a,development-stage pharmaceutical company ... today announced that the,journal Cancer Research published ... target gene against non-small cell lung cancer ...
... Prophylaxis Treatment with Kogenate FS Reduces the,Risk of ... No Pre-Existing,Joint Damage, BERKELEY, Calif., Oct. 10 ... Food and Drug Administration (FDA) has,approved routine prophylaxis ... frequency of bleeding episodes and the risk of,joint ...
Cached Medicine Technology:Quark Pharmaceuticals Announces Publication of Study on Use of siRNA against Proprietary Target for Inhibiting Tumor Growth and Sensitization of Cancer Cells to Chemotherapy 2Quark Pharmaceuticals Announces Publication of Study on Use of siRNA against Proprietary Target for Inhibiting Tumor Growth and Sensitization of Cancer Cells to Chemotherapy 3Quark Pharmaceuticals Announces Publication of Study on Use of siRNA against Proprietary Target for Inhibiting Tumor Growth and Sensitization of Cancer Cells to Chemotherapy 4FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment for Routine Prophylaxis in Children with Hemophilia A 2FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment for Routine Prophylaxis in Children with Hemophilia A 3FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment for Routine Prophylaxis in Children with Hemophilia A 4FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment for Routine Prophylaxis in Children with Hemophilia A 5
(Date:10/25/2014)... CA (PRWEB) October 25, 2014 More ... annual President’s Circle Reception on Monday at the home ... accomplishments and hear from guest speaker Dr. Winifred Lender ... worlds. , Dr. Lender, a Santa Barbara psychologist, author ... challenges and benefits of living in the digital age. ...
(Date:10/25/2014)... 2014 The Wehrman Collaborative, ... IT-accessibility for disabled users by disabled users, has ... to Mackin Educational Resources of Burnsville, Minnesota, for ... and to the Minnesota Alliance for Patient Safety ... Medicine" website. Both organizations have met ...
(Date:10/25/2014)... 2014 Homeowners that are wondering how ... need wonder no more. Clean Crawls gives 5 ... out for when it comes to insulation in their ... article released by Clean Crawls, can cause problems throughout ... insulation that has deteriorated, become damp, or been infested ...
(Date:10/25/2014)... (PRWEB) October 25, 2014 Limbkeepers® announced ... episode of Innovations with Ed Begley Jr, airing 1st ... TBA. , In this episode, Innovations will focus on ... to protect fragile, thinning skin on arms, hands, and ... learn about these versatile products, which help reduce injuries, ...
(Date:10/25/2014)... -- Not getting the right amount of sleep might ... suggests. Those who sleep less or more than ... be more prone to developing the chronic condition, which ... authors concluded that duration and quality of sleep are ... bowel diseases. "Both short and long durations of ...
Breaking Medicine News(10 mins):Health News:Finding Balance between the Real & Digital World Topic of Family Service Agency Reception 2Health News:Finding Balance between the Real & Digital World Topic of Family Service Agency Reception 3Health News:Finding Balance between the Real & Digital World Topic of Family Service Agency Reception 4Health News:IT-Accessibility Award Granted to Education and Health Care for Section 508/WCAG 2Health News:IT-Accessibility Award Granted to Education and Health Care for Section 508/WCAG 3Health News:5 Signs Indicating That Insulation Needs Replacing as Told By Clean Crawls in Recent Article 2Health News:Upcoming Episode of Innovations with Ed Begley, Jr. to Feature Limbkeepers® 2Health News:Sleep Duration Linked to Ulcerative Colitis Risk in Study 2
... married life beat stress better than those live single, says ... buster//. ,Popular perception is that single people have a ... a loving relationship makes it easier to cope with the ... Daily Mail. ,Psychologist Dr Roxane Gervais monitored the ...
... ribosome is the protein-producing nanomachine in cells that keeps ... of Maryland researchers// has provided a clue that could ... HIV AIDS and SARS. ,In the March ... Maryland biology professor Jonathan Dinman and research assistant professor ...
... at Weill Cornell Medical College could prove a potent weapon ... called SS31, is able to cross the blood-brain barrier and ... damage. ,"In our experiments, we found that exposing ... a much smaller area of brain tissue being affected," says ...
... news for working couple in India. A study in the US ... more tended// to become disruptive in class. The effect persisted through ... of the child’s sex or family income, and regardless of the ... $200 million project financed by the National Institute of Child Health ...
... has approved four new drugs manufactured by the Macleods of ... of the four would be used against some strains of ... these four medicines will reinforce efforts to scale up access ... a statement. ,The medicines are the first TB ...
... that some foods and supplements do have an important role ... ‘big C’. At the 233rd national meeting of the American ... papers on this topic will be presented. ,Selected ... for preventing cancer of the esophagus, colon — Using animal ...
Cached Medicine News:Health News:New Ribosome Finding Could Lead to Antiviral Therapies 2Health News:Antioxidant Molecule Could Help Minimize Stroke-Linked Brain Damage 2Health News:Poor Behavior Is Linked to Time in Day Care 2Health News:Indian Pharma Authorized to Market New Anti-TB Drugs 2Health News:Emboldened Warriors-Cancer Fighting Foods 2Health News:Emboldened Warriors-Cancer Fighting Foods 3
Synchron CX3 Delta is a critical care clinical system, providing unparalleled testing speed for the most frequently ordered chemistries-Glucose, BUN, Creatinine, Sodium, Potassium Chloride, CO2 Calci...
Iron (Total/Ferene). Storage temp: 15 - 30 C. Linearity: 0 - 500 ug/dl. Expected values: from males 60 - 160 ug/dl, from females 43 - 140 ug/dl. Available with Calibrator and Number of test are 120....
For the quantitative determination of iron, total iron-binding capacity in human serum....
HDL Cholesterol, liquid....
Medicine Products: