Promacta Now Approved for Aplastic Anemia
August 28, 2014 –The Food and Drug Administration (FDA) extended the approval of Promacta (eltrombopag) to treat severe aplastic anemia and to help maintain platelet counts. Promacta is manufactured by GlaxoSmithKlien. Promacta was originally approved in 2008 for thrombocytopenia (low blood platelet counts) in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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