Myelodysplastic Syndrome

• FDA approval · 2025-10-21
  FDA Approved: DEFERASIROX — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Deferasirox from Actavis Pharma, Inc. This action updates the regulatory status of the product.

• FDA approval · 2025-07-01
  FDA Approved: AZACITIDINE — Supplemental Application (Panacea Biotec Limited)

  FDA approved a supplemental application for azacitidine from Panacea Biotec Limited, allowing the generic azacitidine product to be marketed…

• FDA approval · 2023-11-14
  FDA Approved: DEFERASIROX — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for deferasirox submitted by Sun Pharmaceutical Industries, Inc., approving changes to the product l…

• FDA approval · 2023-09-26
  FDA Approved: DEFERASIROX — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Deferasirox from Bionpharma Inc. under an ANDA, authorizing an additional regulatory action for …

• FDA approval · 2023-08-28
  FDA Approved: REBLOZYL — Supplemental Application (Celgene Corporation)

  FDA approved a supplemental application for Reblozyl (luspatercept) by Celgene Corporation. The action concerns updating the product's label…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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…

• FDA approval · 2022-09-23
  FDA Approved: DEFERASIROX — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva's Deferasirox as an original generic application, enabling broader access to this iron chelation therapy for patients with…

• 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 · 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 · 2021-03-17
  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 · 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 …

• FDA approval · 2020-09-22
  FDA Approved: AZACITIDINE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for Dr. Reddy's azacitidine (AZACITIDINE).

• FDA approval · 2020-07-07
  FDA Approved: INQOVI — Original Application (Taiho Pharmaceutical Co., Ltd.)

  FDA approved INQOVI (cedazuridine and decitabine) from Taiho Pharmaceutical Co., Ltd. under an original NDA (NDA 212576) for adults with mye…

• FDA approval · 2020-06-08
  FDA Approved: AZACITIDINE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic azacitidine (AZACITIDINE) through an Original Application (ANDA 209337). This adds a g…

• 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 · 2020-03-18
  FDA Approved: VIDAZA — Supplemental Application (Celgene Corporation)

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

• FDA approval · 2019-12-30
  FDA Approved: DEFERASIROX — Original Application (Xiromed, LLC)

  FDA approved Xiromed, LLC's generic deferasirox (DEFERASIROX) through an original ANDA.

• FDA approval · 2019-11-20
  FDA Approved: DEFERASIROX — Original Application (Dr. Reddy's Laboratories Inc)

  FDA approved Dr. Reddy's Laboratories' original application for deferasirox, a generic iron chelator used to treat chronic iron overload in …

• FDA approval · 2019-09-09
  FDA Approved: AZACITIDINE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  The FDA approved a supplemental application for azacitidine from Dr. Reddy's Laboratories Inc. (ANDA201537).

• 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 · 2018-10-22
  FDA Approved: AZACITIDINE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for azacitidine from BluePoint Laboratories, indicating an update to the drug's labeling or indicati…

• 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 · 2018-05-11
  FDA Approved: JADENU — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for JADENU (deferasirox) from Novartis Pharmaceuticals Corporation, expanding its labeling for iron …

• FDA approval · 2017-07-28
  FDA Approved: AZACITIDINE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved Dr. Reddy's Laboratories Inc.'s supplemental application for azacitidine. The action pertains to a supplemental filing for the …