Hypereosinophilic Syndrome

• EMA approval · 2026-03-05
  EMA Authorised: Imatinib Teva (imatinib) — Teva B.V.

  EMA authorised Imatinib Teva (imatinib) for multiple indications including chronic myeloid leukemia, precursor cell lymphoblastic leukemia-l…

• EMA approval · 2025-11-12
  EMA Authorised: Glivec (imatinib) — Novartis Europharm Limited

  The European Medicines Agency authorised Glivec (imatinib) for multiple indications, including precursor cell lymphoblastic leukemia-lymphom…

• EMA approval · 2025-05-06
  EMA Authorised: Imatinib Accord (imatinib) — Accord Healthcare S.L.U.

  The EMA authorised Imatinib Accord (imatinib) for several indications, including Precursor Cell Lymphoblastic Leukemia-Lymphoma, Dermatofibr…

• FDA approval · 2025-03-20
  FDA Approved: IMATINIB MESYLATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for imatinib mesylate (Teva) under an ANDA, authorizing continued regulatory approval for this gener…

• FDA approval · 2025-01-08
  FDA Approved: IMATINIB MESYLATE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental ANDA for Imatinib Mesylate (Chartwell RX, LLC), enabling marketing of a generic version of the cancer drug.

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• FDA approval · 2023-08-16
  FDA Approved: IMATINIB — Supplemental Application (Dr.Reddy's Laboratories Inc)

  FDA approved a supplemental application for Imatinib from Dr. Reddy's Laboratories Inc, resulting in regulatory approval for a change to the…

• FDA approval · 2021-03-25
  FDA Approved: IMATINIB — Supplemental Application (Dr.Reddy's Laboratories Inc)

  FDA approved a supplemental application for imatinib from Dr. Reddy's Laboratories, supporting an update to the drug's labeling under the AN…

• FDA approval · 2020-01-09
  FDA Approved: IMATINIB MESYLATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for imatinib mesylate from Teva Pharmaceuticals USA, Inc., under ANDA204285.

• FDA approval · 2016-08-04
  FDA Approved: IMATINIB MESYLATE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approval of Teva's Imatinib Mesylate Original Application under ANDA204285 for a generic Imatinib product.

• FDA approval · 2015-12-03
  FDA Approved: IMATINIB MESYLATE — Original Application (BluePoint Laboratories)

  FDA approved the original application for Imatinib Mesylate from BluePoint Laboratories (ANDA078340), authorizing a generic version of the c…

• FDA approval · 2013-01-25
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for GLEEVEC (imatinib mesylate) submitted by Novartis, reflecting changes to the product 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…