Systemic Mastocytosis

• EMA approval · 2026-01-14
  EMA Authorised: Rydapt (Midostaurin) — Novartis Europharm Ltd

  The European Medicines Agency authorised Rydapt (midostaurin) for additional indications in acute myeloid leukemia and systemic mastocytosis…

• 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.

• 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 · 2023-05-22
  FDA Approved: RYDAPT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for RYDAPT (midostaurin) submitted by Novartis Pharmaceuticals Corporation. The approval updates…

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• FDA approval · 2023-03-09
  FDA Approved: AYVAKIT — Supplemental Application (Blueprint Medicines Corporation)

  FDA approved a supplemental application for AYVAKIT (avapritinib) from Blueprint Medicines Corporation to update the product label (includin…

• FDA approval · 2021-06-16
  FDA Approved: AYVAKIT — Supplemental Application (Blueprint Medicines Corporation)

  FDA approved a supplemental application for AYVAKIT (avapritinib) submitted by Blueprint Medicines Corporation, signaling agency action rela…

• FDA approval · 2021-04-20
  FDA Approved: RYDAPT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for RYDAPT (midostaurin) from Novartis, updating the regulatory status of the product.

• 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 · 2018-06-21
  FDA Approved: RYDAPT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approves a supplemental application for RYDAPT (midostaurin) from Novartis Pharmaceuticals; the update expands or modifies the drug’s la…

• FDA approval · 2017-04-28
  FDA Approved: RYDAPT — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approved RYDAPT (midostaurin) under its original application for an indication in adults with acute myeloid leukemia with FLT3 mutation,…

• 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…