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Promacta FDA Approval History

FDA Approved: Yes (First approved November 20, 2008)
Brand name: Promacta
Generic name: eltrombopag
Dosage form: Tablets
Company: Novartis Pharmaceuticals Corporation
Treatment for: Idiopathic Thrombocytopenic Purpura, Thrombocytopenia, Aplastic Anemia

Promacta (eltrombopag) is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura, thrombocytopenia in patients with chronic hepatitis C, and patients with severe aplastic anemia.

Development timeline for Promacta

Nov 16, 2018Approval FDA Approves Promacta (eltrombopag) for First-Line Severe Aplastic Anemia
Aug 24, 2015Approval FDA Extends Use of Promacta (eltrombopag) in Pediatric Patients with Immune Thrombocytopenic Purpura
Jun 12, 2015Approval FDA Approves Promacta for New Pediatric Chronic Immune Thrombocytopenia (cITP) Indication
Aug 26, 2014Approval FDA Approves New Indication for Promacta (eltrombopag) for Severe Aplastic Anemia
Nov 19, 2012Approval FDA Approves New Indication for Promacta (eltrombopag)
Nov 21, 2008Approval FDA Approves Promacta (eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder
Jun 23, 2008Ligand Partner GlaxoSmithKline Receives FDA Extended Priority Review for Promacta NDA
May 30, 2008Promacta (eltrombopag) Receives Unanimous Recommendation by FDA Advisory Panel
Mar  3, 2008FDA Grants Priority Review for Promacta (eltrombopag)
Dec 21, 2007Ligand Earns $1 Million Milestone Payment as GlaxoSmithKline Submits New Drug Application for Promacta (eltrombopag)
Dec 20, 2007GlaxoSmithKline Files for FDA Approval of Promacta (eltrombopag) to be the First Oral Platelet Growth Factor for Rare Blood Disorder

Further information

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