Acute Myeloid Leukemia

• FDA approval · 2014-09-04
  FDA Approved: BUSULFEX — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved a supplemental application for BUSULFEX (busulfan) submitted by Otsuka America Pharmaceutical, Inc.

• 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 · 2013-06-17
  FDA Approved: CYCLOPHOSPHAMIDE — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for cyclophosphamide from Civica, Inc. under ANDA 040745.

• FDA approval · 2013-05-06
  FDA Approved: VIDAZA — Supplemental Application (Celgene Corporation)

  The FDA approved a Celgene-supplied supplemental application for Vidaza (azacitidine), updating the drug's labeling and/or indications.

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• FDA approval · 2013-02-04
  FDA Approved: DOXORUBICIN HYDROCHLORIDE — Original Application (BluePoint Laboratories)

  FDA approved a generic doxorubicin hydrochloride product under Original Application for BluePoint Laboratories (ANDA 203263). This marks app…

• 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 · 2012-12-05
  FDA Approved: MITOXANTRONE — Supplemental Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved a supplemental application for mitoxantrone from Meitheal Pharmaceuticals Inc., updating the approved generic product under…

• 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 · 2011-11-22
  FDA Approved: IDARUBICIN HYDROCHLORIDE — Supplemental Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved a supplemental application for idarubicin hydrochloride from Meitheal Pharmaceuticals Inc., authorizing a generic version u…

• FDA approval · 2011-04-26
  FDA Approved: MITOXANTRONE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for mitoxantrone hydrochloride from Fresenius Kabi USA, LLC. This approval encompasses the generic p…

• FDA approval · 2006-12-14
  FDA Approved: IDARUBICIN HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved an original application for Idarubicin Hydrochloride by Hikma Pharmaceuticals USA Inc., adding a generic option to the market.