Chronic Myeloid Leukemia

• FDA approval · 2010-10-28
  FDA Approved: DASATINIB — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for dasatinib filed by Prasco Laboratories.

• FDA approval · 2010-03-15
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Tasigna (nilotinib) filed by Novartis Pharmaceuticals Corporation. The approval updates the …

• FDA approval · 2009-08-21
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Tasigna (nilotinib) submitted by Novartis, resulting in updated labeling.

• FDA approval · 2008-12-19
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for GLEEVEC (imatinib mesylate) from Novartis Pharmaceuticals Corporation, resulting in regulatory a…

• FDA approval · 2007-11-08
  FDA Approved: DASATINIB — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for dasatinib submitted by Prasco Laboratories.

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• FDA approval · 2007-10-29
  FDA Approved: TASIGNA — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approved Tasigna (nilotinib) through the original application (NDA022068) for Philadelphia chromosome-positive chronic myeloid leukemia.…

• FDA approval · 2007-09-13
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA supplemental application submitted for GLEEVEC (imatinib mesylate) by Novartis Pharmaceuticals Corporation.

• FDA approval · 2006-10-19
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for GLEEVEC (imatinib mesylate) submitted by 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 · 2006-06-28
  FDA Approved: DASATINIB — Original Application (Prasco Laboratories)

  FDA approved dasatinib under an original application submitted by Prasco Laboratories. The approval covers treatment of Philadelphia chromos…