Sickle Cell Disease

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

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

• FDA approval · 2019-11-25
  FDA Approved: OXBRYTA — Original Application (Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc.)

  FDA approved OXBRYTA (voxelotor) under the original application for the treatment of sickle cell disease.

• FDA approval · 2019-11-15
  FDA Approved: ADAKVEO — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approved ADAKVEO (crizanlizumab) from Novartis as an original biologics license application to reduce the frequency of vaso-occlusive cr…

• FDA approval · 2019-11-01
  FDA Approved: ENDARI — Supplemental Application (Emmaus Medical, Inc.)

  FDA approved a supplemental application for ENDARI (glutamine) by Emmaus Medical, Inc., resulting in an updated regulatory status for the pr…

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• 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 · 2018-12-12
  FDA Approved: SIKLOS — Supplemental Application (Medunik)

  FDA has approved a supplemental application for SIKLOS (hydroxyurea) filed by Medunik.

• 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 · 2017-12-18
  FDA Approved: DROXIA — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for DROXIA (hydroxyurea) submitted by Waylis Therapeutics LLC.

• FDA approval · 2017-07-07
  FDA Approved: ENDARI — Original Application (Emmaus Medical, Inc.)

  FDA approved ENDARI (L-glutamine) from Emmaus Medical, Inc. for reducing acute complications in patients with sickle cell disease.

• FDA approval · 2016-03-23
  FDA Approved: DROXIA — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for DROXIA (hydroxyurea) filed by Waylis Therapeutics LLC.

• FDA approval · 2010-01-28
  FDA Approved: EXJADE — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2006-09-19
  FDA Approved: DROXIA — Supplemental Application (Waylis Therapeutics LLC)

  FDA approves a supplemental application for DROXIA (hydroxyurea) submitted by Waylis Therapeutics LLC.

• FDA approval · 2006-08-15
  FDA Approved: HYDROXYUREA — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for HYDROXYUREA submitted by Endo USA, Inc.

• FDA approval ·
  FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease

  FDA approves Casgevy (exagamglogene autotemcel) as a gene therapy for young children aged 2 years and older with sickle cell disease and rec…