FDA Approves Promacta(R) (Eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Bloo...(sultants are available to assist patient...),Health

Date:11/20/2008

sultants are available to assist patients and healthcare professionals with disease and product-related questions and to help in obtaining the product. More information regarding PROMACTA CARES can be found by calling 1-877-9-PROMACTA or by visiting www.PROMACTACARES.com. Program hours are 8:30 AM to 8:00 PM ET, Mondays through Fridays.

GSK plans to submit a Marketing Authorization Application (MAA) for eltrombopag in the treatment of chronic ITP in Europe in 2008; the proposed trade name is REVOLADE.

PROMACTA milestones

Following the New Drug Application (NDA) filing for PROMACTA in December 2007, the FDA granted the drug Priority Review in March 2008. In addition, the agency granted PROMACTA orphan drug designation for this indication. This is a special status the FDA grants to products that treat a rare disease or condition, affecting less than 200,000 individuals in the United States.(1)

About 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.(2,3) There are estimated to be approximately 60,000 individuals diagnosed with chronic ITP in the U.S.(4) People with chronic ITP often bleed from small blood vessels causing bruises, nosebleeds or even fatal intracerebral bleeds, although these are rare.(3)

About PROMACTA

PROMACTA is an oral, non-peptide thrombopoietin receptor agonist that has been shown in pre-clinical research and clinical trials to stimulate the proliferation and differentiation of megakaryocytes, the bone marrow cells that give rise to blood platelets. PROMACTA was discovered as a result of a research collaboration between GlaxoSmithKline and Ligand Pharmaceuticals (Nasdaq: '/>"/>

SOURCE GlaxoSmithKline Copyright©2008 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5 6 7 8
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