Myelodysplastic Syndromes

• FDA approval · 2017-09-22
  FDA Approved: DECITABINE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal's original ANDA for decitabine, a generic chemotherapy agent. It is indicated for the treatment of myelodysplastic syndr…

• FDA approval · 2017-06-23
  FDA Approved: AZACITIDINE — Original Application (Panacea Biotec Limited)

  FDA approved Panacea Biotec Limited's AZACITIDINE under the original ANDA, confirming approval of a generic azacitidine product.

• FDA approval · 2017-05-31
  FDA Approved: DECITABINE — Original Application (Mylan Institutional LLC)

  FDA approves an Original Application for decitabine as a generic product (ANDA204607) by Mylan Institutional LLC.

• FDA approval · 2017-01-30
  FDA Approved: VIDAZA — Supplemental Application (Celgene Corporation)

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

• FDA approval · 2016-09-29
  FDA Approved: AZACITIDINE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Fresenius Kabi USA, LLC's azacitidine injection as an original application (ANDA) for a generic version. It is approved for the…

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• FDA approval · 2016-08-23
  FDA Approved: VIDAZA — Supplemental Application (Celgene Corporation)

  The FDA approved a supplemental application for Vidaza (azacitidine) submitted by Celgene Corporation, updating/adding to the product's labe…

• FDA approval · 2016-04-29
  FDA Approved: AZACITIDINE — Original Application (BluePoint Laboratories)

  FDA approved azacitidine under the Original Application from BluePoint Laboratories, documenting the initial FDA authorization of the drug. …

• FDA approval · 2016-03-16
  FDA Approved: DECITABINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Decitabine filed by Sun Pharmaceutical Industries, Inc. The approval updates the product's label…

• FDA approval · 2014-01-23
  FDA Approved: DECITABINE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries' original application for decitabine. The drug is used to treat myelodysplastic syndromes and…

• FDA approval · 2013-09-16
  FDA Approved: AZACITIDINE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved the original ANDA for azacitidine from Dr. Reddy's Laboratories Inc., enabling a generic version of the cancer drug. this appro…

• FDA approval · 2013-07-11
  FDA Approved: DECITABINE — Original Application (Dr. Reddy's Laboratories Inc.)

  This FDA page announces the approval of Dr. Reddy's Laboratories' generic decitabine under an Original Application, making a generic version…

• FDA approval · 2012-12-19
  FDA Approved: VIDAZA — Supplemental Application (Celgene Corporation)

  The FDA approved a supplemental application for Vidaza (azacitidine) submitted by Celgene Corporation. This action updates the regulatory st…

• FDA approval · 2012-01-24
  FDA Approved: VIDAZA — Supplemental Application (Celgene Corporation)

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

• FDA approval · 2011-08-17
  FDA Approved: VIDAZA — Supplemental Application (Celgene Corporation)

  The FDA approved a supplemental application for Vidaza (azacitidine) submitted by Celgene Corporation, authorizing changes via a supplementa…

• FDA approval · 2011-08-10
  FDA Approved: EXJADE — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2008-08-20
  FDA Approved: VIDAZA — Supplemental Application (Celgene Corporation)

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

• FDA approval · 2008-02-22
  FDA Approved: VIDAZA — Supplemental Application (Celgene Corporation)

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

• FDA approval · 2007-04-20
  FDA Approved: EXJADE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for EXJADE (deferasirox) submitted by Novartis Pharmaceuticals Corporation, resulting in an approved…