Aplastic Anemia

• 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 (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 …

• 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.

• 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).

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• 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 · 2023-03-16
  FDA Approved: DEFERASIROX — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Deferasirox from Camber Pharmaceuticals, authorizing a generic product under ANDA 216229.

• 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 · 2021-03-17
  FDA Approved: DEFERASOROX — Original Application (Novadoz Pharmaceuticals LLC)

  The FDA granted approval for the original ANDA application of Deferasorox (deferasirox) by Novadoz Pharmaceuticals LLC as a generic product.…

• FDA approval · 2020-06-15
  FDA Approved: DEFERASIROX — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal's generic deferasirox (Deferasirox) as an original ANDA for the treatment of transfusion-related iron overload in pa…

• FDA approval · 2020-04-13
  FDA Approved: DEFERASIROX — Supplemental Application (Xiromed, LLC)

  The FDA approved a supplemental application for deferasirox filed by Xiromed, LLC under an ANDA.

• FDA approval · 2019-04-18
  FDA Approved: BUSULFAN — Original Application (Armas Pharmaceuticals Inc.)

  FDA approved a generic Busulfan from Armas Pharmaceuticals Inc. under ANDA210931, enabling a generic formulation.

• FDA approval · 2018-09-28
  FDA Approved: BUSULFEX — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved a supplemental application for Busultex (busulfan) filed by Otsuka America Pharmaceutical, Inc. The action updates the labeling…

• 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 · 2017-03-09
  FDA Approved: PROMACTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2014-08-26
  FDA Approved: PROMACTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2014-02-10
  FDA Approved: PROMACTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

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