Thrombocytopenia

• EMA approval · 2026-04-08
  EMA Authorised: Doptelet (avatrombopag maleate) — Swedish Orphan Biovitrum AB (publ)

  EMA authorised Doptelet (avatrombopag) for the treatment of thrombocytopenia in the European Union; decision date 22 May 2025. Marketing aut…

• FDA approval · 2026-03-16
  FDA Approved: ELTROMBOPAG — Original Application (Dr. Reddy's Laboratories Inc.,)

  FDA approved eltrombopag from Dr. Reddy's Laboratories under an original application (ANDA219121).

• FDA approval · 2025-07-24
  FDA Approved: DOPTELET SPRINKLE — Original Application (AkaRx, Inc.)

  FDA approved the original application for DOPTELET SPRINKLE (avatrombopag) from AkaRx, Inc.

• FDA approval · 2025-07-24
  FDA Approved: DOPTELET — Supplemental Application (AkaRx, Inc.)

  FDA approved a supplemental application for DOPTELET (avatrombopag) by AkaRx, Inc.

• EMA approval · 2024-12-02
  EMA Authorised: Tavlesse (Fostamatinib disodium) — Instituto Grifols S.A.

  EMA authorised Tavlesse (fostamatinib disodium) for thrombocytopenia, with Instituto Grifols S.A. as the marketing authorisation holder; dec…

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• FDA approval · 2024-04-18
  FDA Approved: ELTROMBOPAG — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for a generic eltrombopag (eltrombopag olamine).

• EMA approval · 2024-02-16
  EMA Authorised: Mulpleo (previously Lusutrombopag Shionogi) (Lusutrombopag) — Shionogi B.V.

  Mulpleo (lusutrombopag) has been authorised in the EU for thrombocytopenia with Shionogi B.V. as the marketing authorisation holder.

• FDA approval · 2023-11-29
  FDA Approved: ALVAIZ — Original Application (Teva Pharmaceuticals, Inc.)

  ALVAIZ (eltrombopag) from Teva received FDA approval through an original application for the treatment of thrombocytopenia conditions by inc…

• FDA approval · 2021-10-14
  FDA Approved: DOPTELET — Supplemental Application (AkaRx, Inc.)

  FDA approved a supplemental application for DOPTELET (avatrombopag maleate) from AkaRx, Inc., likely to modify the label or add/expand an in…

• FDA approval · 2018-07-31
  FDA Approved: MULPLETA — Original Application (Eddingpharm (U. S. ) Inc.)

  The FDA granted original approval for Mulpleta (lusutrombopag) for adults with chronic liver disease to raise platelet counts in advance of …

• FDA approval · 2018-05-21
  FDA Approved: DOPTELET — Original Application (AkaRx, Inc.)

  FDA approved DOPTELET (avatrombopag) from AkaRx, Inc. for reducing the need for platelet transfusions in adults with chronic liver disease u…