Acute Myeloid Leukemia

• FDA approval · 2024-03-29
  FDA Approved: AZACITIDINE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for azacitidine from Accord Healthcare Inc., enabling continued regulatory authorization of the gene…

• FDA approval · 2023-12-21
  FDA Approved: IDHIFA — Supplemental Application (Celgene Corporation)

  FDA approved a supplemental application for IDHIFA (enasidenib mesylate) to expand its labeling for acute myeloid leukemia with IDH2 mutatio…

• FDA approval · 2023-07-20
  FDA Approved: VANFLYTA — Original Application (Daiichi Sankyo Inc.)

  FDA approved VANFLYTA (quizartinib) for adults with newly diagnosed FLT3-ITD–positive acute myeloid leukemia in combination with standard in…

• FDA approval · 2023-06-28
  FDA Approved: AZACITIDINE — Original Application (Apotex Corp)

  FDA approved Apotex Corp's generic azacitidine (AZACITIDINE) under an original ANDA; the product is indicated for treating certain myelodysp…

• FDA approval · 2023-06-15
  FDA Approved: CYTARABINE — Supplemental Application (Meitheal Pharmaceuticals Inc.)

  FDA approved a supplemental application for Cytarabine from Meitheal Pharmaceuticals Inc., completing a modification to the existing Cytarab…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• EMA approval · 2023-04-19
  EMA Authorised: Ceplene (histamine dihydrochloride) — Laboratoires Delbert

  Authorised status for Ceplene (histamine dihydrochloride) for acute myeloid leukemia/therapy by Laboratoires Delbert in the EU.

• FDA approval · 2023-03-27
  FDA Approved: DAURISMO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for DAURISMO (glasdegib) submitted by Pfizer Laboratories Div Pfizer Inc. The action relates to …

• FDA approval · 2022-12-01
  FDA Approved: REZLIDHIA — Original Application (Rigel Pharmaceuticals, Inc.)

  The FDA approved Rezlidhia (olutasidenib) through an original application for adults with IDH1-mutant acute myeloid leukemia.

• FDA approval · 2022-09-27
  FDA Approved: VYXEOS — Supplemental Application (Jazz Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for VYXEOS (daunorubicin and cytarabine liposome) from Jazz Pharmaceuticals, Inc. This action re…

• FDA approval · 2022-09-23
  FDA Approved: VIDAZA — Supplemental Application (Celgene Corporation)

  The FDA approved a supplemental application for Vidaza (azacitidine) submitted by Celgene Corporation.

• FDA approval · 2022-05-20
  FDA Approved: VIDAZA — Supplemental Application (Celgene Corporation)

  FDA approved a supplemental application for Vidaza (azacitidine) submitted by Celgene Corporation.

• FDA approval · 2022-04-15
  FDA Approved: DECITABINE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic decitabine via an Original Application, enabling the same indications as the brand pro…

• FDA approval · 2022-03-24
  FDA Approved: INQOVI — Supplemental Application (Taiho Pharmaceutical Co., Ltd.)

  The FDA approved a supplemental application for INQOVI, the oral fixed-dose combination of cedazuridine and decitabine from Taiho Pharmaceut…

• FDA approval · 2022-02-28
  FDA Approved: CYTARABINE — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approves Meitheal Pharmaceuticals' original application for CYTARABINE (cytarabine) as a generic injectable product, enabling its ma…

• FDA approval · 2022-01-27
  FDA Approved: IDARUBICIN HYDROCHLORIDE — Supplemental Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved a supplemental application for idarubicin hydrochloride filed by Meitheal Pharmaceuticals Inc. This action completes the su…

• FDA approval · 2022-01-21
  FDA Approved: BUSULFAN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Busulfan by Amneal Pharmaceuticals LLC, updating the approval for this generic product.

• FDA approval · 2022-01-12
  FDA Approved: XOSPATA — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for XOSPATA (gilteritinib) submitted by Astellas Pharma US, Inc.

• FDA approval · 2021-09-29
  FDA Approved: DECITABINE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for decitabine from Accord Healthcare Inc. under an ANDA, marking an updated approval for the generi…

• FDA approval · 2021-07-02
  FDA Approved: DECITABINE — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals’ decitabine as an Original Application (ANDA), providing a generic injectable option. The approval cov…

• FDA approval · 2021-06-25
  FDA Approved: DECITABINE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for decitabine (generic) submitted by Mylan Institutional LLC.

• FDA approval · 2021-05-17
  FDA Approved: ONUREG — Supplemental Application (Celgene Corporation)

  The FDA approved a supplemental application for ONUREG (azacitidine) from Celgene Corporation, expanding its labeling to include maintenance…

• FDA approval · 2021-03-30
  FDA Approved: VYXEOS — Supplemental Application (Jazz Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for VYXEOS (daunorubicin and cytarabine liposome) from Jazz Pharmaceuticals, Inc.

• FDA approval · 2021-03-17
  FDA Approved: DECITABINE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for decitabine by BluePoint Laboratories, authorizing a generic version of the drug.

• FDA approval · 2021-02-10
  FDA Approved: IDAMYCIN PFS — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Idamycin PFS (idarubicin hydrochloride) from Pfizer, updating the drug’s approval to include a n…

• FDA approval · 2021-01-25
  FDA Approved: DECITABINE — Supplemental Application (Novadoz Pharmaceuticals LLC)

  FDA approved a supplemental application for decitabine (generic) submitted by Novadoz Pharmaceuticals LLC. The approval relates to the ANDA …