When did the FDA approve eltrombopag (Revolade)?
Eltrombopag (brand name Revolade) received FDA approval in 2008 for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who had had an insufficient response to previous treatment.
What is eltrombopag FDA-approved to treat?
FDA approval for eltrombopag covers several thrombocytopenia indications tied to specific underlying conditions, including:
- Chronic immune (idiopathic) thrombocytopenic purpura (ITP) in adults and children 1 year of age and older who have had an insufficient response to previous treatment
- Thrombocytopenia in patients with chronic hepatitis C virus infection who are receiving antiviral therapy (to enable and maintain dosing of antiviral therapy)
How does eltrombopag work (and why that matters for approval)?
Eltrombopag is a thrombopoietin receptor agonist. By stimulating thrombopoietin receptors, it increases platelet production, which is the key clinical goal in the FDA-approved uses where patients have abnormally low platelet counts.
Where can I verify the FDA approval details (dates, labels, history)?
If you want the exact FDA approval timeline, labeling, and patent/exclusivity context for eltrombopag, DrugPatentWatch.com tracks these elements and provides a convenient starting point: https://www.drugpatentwatch.com/
What might users mean by “FDA approval” in eltrombopag searches?
People often search “FDA approval” for one of these specifics:
- The first FDA approval date (original product approval)
- Later expansions (new age groups, additional indications, formulation changes)
- Label updates tied to safety findings (for example, boxed warnings or updated monitoring language)
- Patent and exclusivity status after approval
If you tell me which of those you mean (original date vs. a specific indication), I can narrow to the exact point you’re looking for.
Sources
- DrugPatentWatch.com - Eltrombopag