Immune Thrombocytopenia

• 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).

• EMA approval · 2026-02-25
  EMA Authorised: Eltrombopag Accord (eltrombopag olamine) — Accord Healthcare S.L.U.

  The EU's EMA authorised the brand product Eltrombopag Accord (eltrombopag olamine) for treatment of immune thrombocytopenia. The marketing a…

• EMA approval · 2026-02-05
  EMA Authorised: Eltrombopag Viatris (eltrombopag olamine) — Viatris Limited

  The EMA authorised Viatris' eltrombopag olamine (Eltrombopag Viatris) for immune thrombocytopenia (idiopathic thrombocytopenic purpura), est…

• FDA approval · 2026-01-15
  FDA Approved: ALVAIZ — Supplemental Application (Teva Pharmaceuticals, Inc.)

  The FDA approved Teva's supplemental application for ALVAIZ (eltrombopag).

• FDA approval · 2026-01-14
  FDA Approved: ELTROMBOPAG — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved an original application for eltrombopag olamine from Novadoz Pharmaceuticals LLC.

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• FDA approval · 2026-01-14
  FDA Approved: ELTROMBOPAG — Original Application (Zydus Pharmaceuticals USA Inc.)

  Zydus Pharmaceuticals USA Inc. received FDA approval for an original application of eltrombopag (generic), a thrombopoietin receptor agonist…

• FDA approval · 2026-01-14
  FDA Approved: ELTROMBOPAG OLAMINE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals NY LLC's eltrombopag olamine as an Original Application (ANDA), making a generic version of eltrombopag …

• EMA approval · 2025-05-16
  EMA Authorised: Deqsiga (human normal immunoglobulin) — Takeda Manufacturing Austria AG

  EMA authorised Deqsiga, a human normal immunoglobulin product from Takeda Manufacturing Austria AG, for several immunologic and neuropathic …

• FDA approval · 2025-02-04
  FDA Approved: TAVALISSE — Supplemental Application (Rigel Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for TAVALISSE (fostamatinib) submitted by Rigel Pharmaceuticals, Inc.

• FDA approval · 2025-01-17
  FDA Approved: ELTROMBOPAG — Original Application (XLCare Pharmaceuticals Inc.)

  FDA approves a generic eltrombopag product under an original application (ANDA 206788) submitted by XLCare Pharmaceuticals 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…

• 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).

• 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 · 2022-11-15
  FDA Approved: PROMACTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for PROMACTA (eltrombopag olamine) from Novartis, resulting in updated labeling and potential expans…

• FDA approval · 2022-03-31
  FDA Approved: PROMACTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for PROMACTA (eltrombopag olamine) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2022-02-10
  FDA Approved: NPLATE — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for NPLATE (romiplostim) from Amgen. This action updates the product’s labeling as described in …

• FDA approval · 2021-02-10
  FDA Approved: NPLATE — Supplemental Application (Amgen, Inc)

  FDA approved Amgen's supplemental application for NPLATE (romiplostim), approving changes to the product labeling.

• FDA approval · 2020-11-23
  FDA Approved: NPLATE — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for NPLATE (romiplostim) from Amgen to expand its labeling.

• FDA approval · 2020-08-20
  FDA Approved: DOPTELET — Supplemental Application (AkaRx, Inc.)

  FDA approved a supplemental application for DOPTELET (avatrombopag maleate) from AkaRx, Inc., likely expanding labeling or indications.

• FDA approval · 2020-04-29
  FDA Approved: PROMACTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for PROMACTA (eltrombopag olamine) by Novartis Pharmaceuticals Corporation. This action updates the …

• FDA approval · 2019-10-17
  FDA Approved: NPLATE — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for NPLATE (romiplostim) from Amgen.

• FDA approval · 2018-12-14
  FDA Approved: NPLATE — Supplemental Application (Amgen, Inc)

  The FDA approved Amgen's supplemental application for NPLATE (romiplostim), approving changes included in the submission (such as updates to…

• FDA approval · 2018-04-17
  FDA Approved: TAVALISSE — Original Application (Rigel Pharmaceuticals, Inc.)

  FDA approved TAVALISSE (fostamatinib) via an original application for adults with chronic immune thrombocytopenia.

• FDA approval · 2017-10-04
  FDA Approved: PROMACTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for PROMACTA (eltrombopag olamine) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2017-06-05
  FDA Approved: NPLATE — Supplemental Application (Amgen, Inc)

  FDA approved Amgen's supplemental application for NPLATE (romiplostim), resulting in updated labeling for the product.