Myelodysplastic Syndromes

• 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 · 2021-09-20
  FDA Approved: DECITABINE — Original Application (Eugia US LLC)

  FDA approved Eugia US LLC's original application for a generic decitabine product indicated for myelodysplastic syndromes.

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• FDA approval · 2021-08-05
  FDA Approved: LENALIDOMIDE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved a supplemental application for lenalidomide by Teva Pharmaceuticals, approving changes related to the drug's use.

• 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 · 2021-04-12
  FDA Approved: DECITABINE — Original Application (Qilu Pharmaceutical Co., Ltd.)

  The FDA approved an original ANDA for decitabine from Qilu Pharmaceutical Co., Ltd.

• 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 · 2020-11-23
  FDA Approved: DECITABINE — Original Application (Gland Pharma Limited)

  FDA approves a new original generic application for decitabine (Gland Pharma Limited).

• FDA approval · 2020-11-10
  FDA Approved: DECITABINE — Supplemental Application (Mylan Institutional LLC)

  The FDA approved a supplemental application for Decitabine submitted by Mylan Institutional LLC under the ANDA process.

• FDA approval · 2020-09-16
  FDA Approved: DECITABINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Decitabine submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2020-08-06
  FDA Approved: AZACITIDINE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for azacitidine submitted by Fresenius Kabi USA, LLC.

• FDA approval · 2020-07-13
  FDA Approved: AZACITIDINE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for azacitidine submitted by BluePoint Laboratories, representing a modification to the existing NDA…

• FDA approval · 2020-06-26
  FDA Approved: CYTARABINE — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approval of Meitheal Pharmaceuticals' original ANDA for Cytarabine (cytarabine), a generic injectable anticancer agent.

• 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 · 2020-02-03
  FDA Approved: DECITABINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for decitabine submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2019-10-09
  FDA Approved: DECITABINE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for Decitabine from Dr. Reddy's Laboratories Inc., expanding regulatory approval for this generic hy…

• FDA approval · 2019-09-16
  FDA Approved: DECITABINE — Original Application (BluePoint Laboratories)

  The FDA approved BluePoint Laboratories’ original application for decitabine as a generic injectable, establishing a generic version of the …

• FDA approval · 2019-08-28
  FDA Approved: DECITABINE — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approves the original application for decitabine (generic) from Novadoz Pharmaceuticals LLC, enabling its marketing for the treatment of…

• FDA approval · 2019-07-22
  FDA Approved: AZACITIDINE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s supplemental application for azacitidine.

• FDA approval · 2019-05-24
  FDA Approved: EXJADE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Exjade (deferasirox) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2019-05-22
  FDA Approved: DECITABINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for DECITABINE, submitted by Sun Pharmaceutical Industries, Inc. This action updates the regulatory …

• FDA approval · 2018-07-02
  FDA Approved: AZACITIDINE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s original application for azacitidine, providing a generic version of the cancer drug indicated for mye…

• FDA approval · 2018-01-10
  FDA Approved: AZACITIDINE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for azacitidine submitted by BluePoint Laboratories. This indicates regulatory approval of modif…