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