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Eltrombopag News

FDA Extends Use of Promacta (eltrombopag) in Pediatric Patients with Immune Thrombocytopenic Purpura

Posted 24 Aug 2015 by Drugs.com

August 24, 2015 – The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in these children when they have not achieved an appropriate response using other ITP medicines or surgery to remove th ...

Promacta Approval Expanded to Kids With Rare Blood Disorder

Posted 24 Aug 2015 by Drugs.com

MONDAY, Aug. 24, 2015 – U.S. Food and Drug Administration approval of the drug Promacta (eltrombopag) has been expanded to include children one year and older with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). ITP is characterized by a low blood platelet count. Promacta is now approved for the disorder among children who have had unsatisfactory results with other ...

FDA Approves Promacta for New Pediatric Chronic Immune Thrombocytopenia (cITP) Indication

Posted 14 Jun 2015 by Drugs.com

SAN DIEGO, June 12, 2015 --(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that the FDA has approved a supplemental New Drug Application (sNDA) for the use of Promacta (eltrombopag), a Novartis product, for the treatment of children six years and older with chronic immune thrombocytopenia (cITP) who have had an insufficient response to corticosteroids, ...

FDA Approves New Indication for Promacta (eltrombopag) for Severe Aplastic Anemia

Posted 27 Aug 2014 by Drugs.com

London, UK – 26 August 2014 – GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the once-daily use of Promacta (eltrombopag) in patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).1 SAA is a blood disorder where the bone ...

FDA Approves New Indication for Promacta (eltrombopag)

Posted 20 Nov 2012 by Drugs.com

LONDON, Nov. 19, 2012 – GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved Promacta for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.  Promacta is the first supportive care treatment available to patients who are ineligible or poor ...

FDA Announces Changes to Risk Strategy Requirements for Two Drugs to Treat Low Platelet Counts

Posted 7 Dec 2011 by Drugs.com

Includes labeling revisions for both drugs The approval of changes to the Risk Evaluation and Mitigation Strategies (REMS) for both Nplate (romiplostim) and Promacta (eltrombopag) was announced by the U.S. Food and Drug Administration. An FDA-initiated review of the current information has determined that while safety risks for both Nplate and Promacta still exist, certain restrictive ...

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Further Information

Related Condition Support Groups

Idiopathic (Immune) Thrombocytopenic Purpura, Aplastic Anemia, Thrombocytopenia, Thrombocytopenia Idiopathic

Related Drug Support Groups

Promacta

Eltrombopag Patient Information at Drugs.com