Gastrointestinal Stromal Tumor

• FDA approval · 2021-12-06
  FDA Approved: SUNITINIB MALATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved a generic version of sunitinib malate submitted by Mylan Pharmaceuticals Inc., for use in cancer indications shared with the re…

• FDA approval · 2021-08-30
  FDA Approved: SUTENT — Supplemental Application (U.S. Pharmaceuticals)

  The FDA approved a supplemental application for Sutent (sunitinib malate) submitted by U.S. Pharmaceuticals, enabling an updated indication …

• FDA approval · 2021-08-16
  FDA Approved: SUNITINIB MALATE — Original Application (NorthStar RxLLC)

  FDA approved the original application for sunitinib malate, authorizing a generic version of the cancer drug from NorthStar RxLLC.

• FDA approval · 2021-06-17
  FDA Approved: QINLOCK — Supplemental Application (Deciphera Pharmaceuticals, LLC)

  The FDA approved a supplemental application for QINLOCK (ripretinib) submitted by Deciphera Pharmaceuticals.

• 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…

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• 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 · 2020-08-10
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for GLEEVEC (imatinib mesylate) from Novartis, approving changes to the product labeling based o…

• FDA approval · 2020-07-23
  FDA Approved: IMATINIB MESYLATE — Original Application (BluePoint Laboratories)

  FDA approved imatinib mesylate as an original-application generic drug for BluePoint Laboratories.

• FDA approval · 2020-05-15
  FDA Approved: QINLOCK — Original Application (Deciphera Pharmaceuticals, LLC)

  The FDA approved Qinlock (ripretinib) by original application for the treatment of adults with unresectable or metastatic gastrointestinal s…

• FDA approval · 2020-01-09
  FDA Approved: AYVAKIT — Original Application (Blueprint Medicines Corporation)

  FDA approved AYVAKIT (avapritinib) under the original NDA for adults with unresectable or metastatic gastrointestinal stromal tumors harbori…

• 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 · 2019-01-17
  FDA Approved: IMATINIB MESYLATE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories' imatinib mesylate as an original application for a generic version of the cancer drug, for the same indica…

• FDA approval · 2019-01-17
  FDA Approved: IMATINIB MESYLATE — Original Application (Chartwell RX, LLC)

  FDA approves an original ANDA for imatinib mesylate, granting Chartwell RX, LLC a generic version (ANDA 208429).

• FDA approval · 2018-08-13
  FDA Approved: IMATINIB — Original Application (Dr.Reddy's Laboratories Inc)

  FDA approved the original application for imatinib from Dr. Reddy's Laboratories Inc, enabling the generic product to be marketed in the Uni…

• FDA approval · 2017-11-16
  FDA Approved: SUTENT — Supplemental Application (U.S. Pharmaceuticals)

  FDA has approved a supplemental application for Sutent (sunitinib malate) submitted by U.S. Pharmaceuticals. This entry documents the supple…

• FDA approval · 2017-09-29
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approves a supplemental NDA for GLEEVEC (imatinib mesylate) filed by Novartis Pharmaceuticals Corporation, resulting in changes to the p…

• FDA approval · 2017-06-21
  FDA Approved: IMATINIB MESYLATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved Mylan's original application for imatinib mesylate tablets, a generic version of Gleevec, for the same indications as the refer…

• FDA approval · 2016-08-25
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2016-08-17
  FDA Approved: IMATINIB MESYLATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's supplemental application for imatinib mesylate, a generic version of the cancer drug, to update its approval status.

• 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 · 2016-06-07
  FDA Approved: STIVARGA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Stivarga (regorafenib) submitted by Bayer HealthCare Pharmaceuticals Inc.

• 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 · 2015-04-24
  FDA Approved: SUTENT — Supplemental Application (U.S. Pharmaceuticals)

  FDA approved a supplemental application for Sutent (sunitinib malate) submitted by U.S. Pharmaceuticals.

• FDA approval · 2014-12-19
  FDA Approved: SUTENT — Supplemental Application (U.S. Pharmaceuticals)

  The FDA approved a supplemental application for Sutent (sunitinib malate) submitted by U.S. Pharmaceuticals.

• FDA approval · 2014-09-25
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tasigna (nilotinib) submitted by Novartis Pharmaceuticals Corporation.