Navigation Links
FDA Grants Full Approval for PROMACTA® (eltrombopag) for Treatment of Rare Blood Disorder
Date:2/25/2011

PHILADELPHIA, Feb. 25, 2011 /PRNewswire/ -- GlaxoSmithKline (NYSE: GSK) today announced that the United States Food and Drug Administration (FDA) granted full approval for PROMACTA® (eltrombopag), an oral tablet that can raise platelet counts in patients with the rare blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

PROMACTA initially received FDA orphan drug designation in May 2008 and accelerated approval in November 2008 for chronic ITP.  The FDA Accelerated Approval program offers a pathway to gain provisional marketing approval for therapies that address unmet patient needs.  Full approval of the therapy requires completion of post-marketing clinical trials and commitments that verify clinical benefit.

"Full approval of PROMACTA was based on clinical studies that provide physicians and patients with a broader understanding of its treatment effect and safety profile," said Steven Stein, MD, V.P. of Medicines Development, GlaxoSmithKline.  "PROMACTA is a testament to how the FDA Accelerated Approval Program supports development of therapies that meet unmet patient needs. Patients with limited treatment options gained access to PROMACTA while GSK conducted clinical studies that yielded additional efficacy and safety data."  

About Chronic ITP

Chronic ITP is a disorder marked by increased platelet destruction and/or inadequate platelet production in the blood, which causes an increased risk of bruising and bleeding. There are estimated to be approximately 60,000 individuals diagnosed with chronic ITP in the U.S.  People with chronic ITP often bleed from small blood vessels causing bruises or nosebleeds.

Updated Prescribing Information (PI)

The major changes in the Prescribing Inform
'/>"/>

SOURCE GlaxoSmithKline
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. US FDA Grants Orphan Drug Status to Immtechs Pafuramidine for Treatment of African Sleeping Sickness
2. Chinese SFDA Grants Immtech Fast Track Status
3. Ethics Group Asks USAID Inspector General to Investigate Legality of Grants to Soros Groups
4. NTMir Announces Research Grants for Epidemiology and Household Water as Source of Infection
5. FDA Grants Approval to Extend U.S. Enrollment and Clinical Trial
6. FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel
7. FDA Grants Priority Review for ACIPHEX(R) (rabeprazole sodium) sNDA for Short-Term Treatment of GERD in Adolescents
8. FDA Grants Priority Review for PROMACTA(R) (eltrombopag)
9. FDA Grants NeoVistas Request to Expand CABERNET Trial to 30 Sites in the U.S.
10. FDA Grants Market Clearance for the LipiScan(TM) Coronary Imaging System Developed by InfraReDx, Inc. - A Novel Spectroscopy System for the Identification of Lipid Core Containing Plaques of Interest in the Coronary Arteries
11. FDA Grants Pediatric Exclusivity for TOPAMAX(R), Extending the Marketing Exclusivity by Six Months
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... , Jan. 15, 2014  Research and Markets ... the "Dental Consumables Market - Global Industry ... - 2018" report to their offering. ... ) Dental consumables are products which are ... impairments, for tooth restoration and in treatment of ...
(Date:1/15/2014)... , Jan. 15, 2014  Novation, the leading ... company, awarded several new IT value-added reseller (VAR) ... hospital organizations with IT goods and services at ... agreements, as well as value-added services such as ... New Novation agreements were awarded to ...
(Date:1/15/2014)... DUBLIN , January 15, 2014 ... that it has waived the Office of Fair Trading (OFT) ... the outstanding shares of ViroPharma Incorporated (NASDAQ: VPHM).   ... no longer conditional on OFT approval, and Shire expects to ... currently scheduled expiration time, subject to the satisfaction of all ...
Breaking Medicine Technology:Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 2Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 3New Novation Information Technology VAR Contracts Offer Significant Savings to Hospitals 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 3
... Products Company, Inc. has announced the addition of Florida ... Systems. Florida Metrology, based in Jupiter, ... Systems is a line of highly accurate portable metrology ... across the United States. Tim Row of Florida Metrology ...
... FOUNTAIN HILLS, Ariz., Dec. 8, 2010 Sunridge International ... that Ameco Medical is preparing to start the short ... Ameco Medical Equipment L.L.C., Sunridge,s exclusive distributor for ... Bores, Sunridge,s medical consultant, to attend the start of ...
Cached Medicine Technology:Florida Metrology To Distribute OASIS Inspection Systems 2
(Date:4/14/2014)... treat children with uncomplicated acute appendicitis is a reasonable ... fewer missed school days, according to a pilot study. ... Hospital and published online April 12 in the ... the first prospective study on nonoperative management of acute ... , Researchers enrolled 77 patients age 7 to 17 ...
(Date:4/14/2014)... 2014, Perth, Australia. Drug discovery company Proteomics International ... of a companion diagnostic (CDx) test with the ... The research team authenticated the panel of biomarkers ... samples. Seven biomarkers were validated at high stringency ... The mass spectrometry data was then cross-validated using ...
(Date:4/14/2014)... 2014) When it comes to the cost and ... Patients get the best care when they are treated ... extensive experience in their current job, according to a ... and Columbia Business School. The study was published in ... Applied Economics . , The review of more ...
(Date:4/13/2014)... STANFORD, Calif. A low-cost empowerment program for ... and sexual harassment of these girls, who live ... and are frequently attacked, a large new study ... Stanford University School of Medicine, Lucile Packard Children,s ... No Worldwide, validated the program,s effectiveness in combating ...
(Date:4/11/2014)... the processes that control brain cell production could pave ... brain-related disorders. , Scientists have gained new understanding of ... how and when nerve and brain cells are formed ... and keeps it healthy. Their findings could help explain ... which is a fundamental characteristic of many diseases including ...
Breaking Medicine News(10 mins):Health News:Antibiotics alone are a successful treatment for uncomplicated acute appendicitis in kids 2Health News:Antibiotics alone are a successful treatment for uncomplicated acute appendicitis in kids 3Health News:Longer nurse tenure on hospital units leads to higher quality care 2Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 2Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 3Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 4
... INDIANAPOLIS An orphan drug originally used for HIV treatment ... additional sensitivity and pain from opioid use. The study by ... in the March 25, 2011 issue of Brain, Behavior ... in animal models may ultimately make morphine a safer and ...
... , THURSDAY, March 24 (HealthDay News) -- Children ... control more quickly and accurately than those without the ... characterized by repeated involuntary sounds and physical movements called ... or -- in rare adult cases -- blurting out ...
... is available in French and Spanish . ... of Granada , belonging to the Laboratorio de Ciencias de la ... night vision, and the tool required to implement it, which has ... Software Halo v1.0, and a computer where the mouse is used ...
... Nick Harvey of the MRC Lifecourse Epidemiology Unit, Southampton, ... of Lige, Lige, Belgium were presented with the ESCEO ... at a ceremony held during the European Congress on ... Spain. The Awards, valued at 2,500, recognize young ...
... China, investigated eye movements in Chinese and British people to ... how they compare between different human populations. They found ... British people, is much more common in Chinese people, suggesting ... different populations. Tests of eye movements can ...
... Even mild stress can cause long-term disability that prevents people ... been known that mental disorders can be a cause of ... forms of stress should be taken more seriously, according to ... Kingdom, and colleagues. The study included over 17,000 employed ...
Cached Medicine News:Health News:A safer, more effective morphine may be possible with Indiana University discovery 2Health News:Children With Tourette Syndrome Have Better Motor Control, Study Finds 2Health News:Researchers develop a halometer that tests alterations in night vision 2Health News:Researchers develop a halometer that tests alterations in night vision 3Health News:Eye movement differs in British and Chinese populations 2Health News:Even Mild Stress Can Lead to Disability, Study Says 2
... offers accuracy, speed, ease of use, ... is an Auto Refractor/Keratometer with both ... elevation, automatic alignment, focusing, printing, high-speed ... other features that have made the ...
Neomycin and Polymyxin B Sulfates and Hydrocortisone otic suspension, USP is a sterile antibacterial and anti-inflammatory suspension for otic use....
Neomycin and Polymyxin B Sulfates and Hydrocortisone ophthalmic suspension is a sterile antimicrobial and anti-inflammatory suspension for ophthalmic use....
Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment is a multiple dose anti-infective steroid combination in sterile ointment form for topical applications....
Medicine Products: