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Doptelet FDA Approval History

Last updated by Judith Stewart, BPharm on July 29, 2025.

FDA Approved: Yes (First approved May 21, 2018)
Brand name: Doptelet
Generic name: avatrombopag
Dosage form: Tablets and Oral Granules
Company: Dova Pharmaceuticals, Inc.
Treatment for: Thrombocytopenia, Immune Thrombocytopenia

Doptelet (avatrombopag) is a second generation, orally administered thrombopoietin receptor agonist (TPO-RA) for use in the treatment of thrombocytopenia.

Development timeline for Doptelet

DateArticle
Jul 25, 2025Approval Sobi Announces U.S. Food and Drug Administration Approves Doptelet (avatrombopag) for the Treatment of Thrombocytopenia in Pediatric Patients One Year and Older with Persistent or Chronic Immune Thrombocytopenia (ITP)
Jun 27, 2019Approval Dova Pharmaceuticals Announces FDA Approval of Doptelet (avatrombopag) for Treatment of Chronic Immune Thrombocytopenia (ITP)
May 21, 2018Approval FDA Approves Doptelet (avatrombopag) for Chronic Liver Disease Patients with Thrombocytopenia who are Undergoing a Medical Procedure
Nov 27, 2017Dova Pharmaceuticals Announces FDA Acceptance of the Avatrombopag New Drug Application (NDA) with Priority Review
Sep 22, 2017Dova Pharmaceuticals Announces New Drug Application Submission to FDA for Avatrombopag, a Second Generation Thrombopoietin Receptor Agonist

Further information

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