Pancreatic Neuroendocrine Tumor

• FDA approval · 2025-10-30
  FDA Approved: EVEROLIMUS — Original Application (Novugen Pharma (USA) LLC.)

  FDA approved a generic version of Everolimus from Novugen Pharma (USA) LLC under an Original Application (ANDA).

• FDA approval · 2025-02-14
  FDA Approved: SUNITINIB MALATE — Original Application (Novadoz Pharmaceuticals LLC)

  The FDA approved an original generic application for sunitinib malate from Novadoz Pharmaceuticals LLC. This approval provides a generic opt…

• FDA approval · 2024-09-27
  FDA Approved: BYNFEZIA PEN — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved BYNFEZIA PEN (octreotide acetate) under an original NDA from Sun Pharmaceutical Industries. The product is an autoinjector pen …

• FDA approval · 2024-04-30
  FDA Approved: EVEROLIMUS — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Everolimus submitted by Hikma Pharmaceuticals USA Inc. This action updates approved labeling…

• FDA approval · 2023-08-21
  FDA Approved: SUNITINIB MALATE — Supplemental Application (NorthStar RxLLC)

  The FDA approved a supplemental application for SUNITINIB MALATE (sunitinib malate) filed by NorthStar RxLLC.

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• FDA approval · 2023-08-21
  FDA Approved: SUNITINIB MALATE — Original Application (Novugen Pharma (USA) LLC.)

  FDA approves a generic version of sunitinib malate from Novugen Pharma (USA) LLC under an Original Application (ANDA 218012).

• FDA approval · 2023-06-30
  FDA Approved: OCTREOTIDE — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for octreotide acetate filed by Fresenius Kabi USA, LLC.

• FDA approval · 2023-02-21
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application to Heritage Pharmaceuticals (Avet) for octreotide acetate, a generic product, under an ANDA.

• FDA approval · 2022-04-11
  FDA Approved: SUNITINIB MALATE — Original Application (Dr.Reddys Laboratories Inc)

  FDA approved a generic version of sunitinib malate (SUNITINIB MALATE) from Dr. Reddy's Laboratories Inc under Original Application.

• 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 · 2021-10-18
  FDA Approved: EVEROLIMUS — Original Application (Par Health USA, LLC)

  FDA approved Par Health USA, LLC's Original Application for EVEROLIMUS (a generic version of everolimus). The approval enables the generic p…

• 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 · 2021-02-11
  FDA Approved: EVEROLIMUS — Original Application (NorthStar RxLLC)

  FDA approved NorthStar RxLLC's original application (ANDA) for Everolimus, a generic version of the mTOR inhibitor. The approval enables a g…

• FDA approval · 2020-06-08
  FDA Approved: EVEROLIMUS — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic Everolimus under an Original Application, enabling the sale of a generic version of th…

• FDA approval · 2020-02-13
  FDA Approved: AFINITOR — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Afinitor (everolimus) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2020-02-03
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for octreotide acetate from Heritage Pharmaceuticals Inc. (Avet Pharmaceuticals Inc.).

• FDA approval · 2020-02-03
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for octreotide acetate from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. under …

• FDA approval · 2019-04-11
  FDA Approved: SANDOSTATIN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Sandostatin (octreotide acetate) from Novartis Pharmaceuticals Corporation under NDA 019667.

• FDA approval · 2018-12-12
  FDA Approved: SOMATULINE DEPOT — Supplemental Application (Ipsen Biopharmaceuticals, Inc.)

  The FDA approved a supplemental application for Somatuline Depot (lanreotide acetate) from Ipsen Biopharmaceuticals, Inc., resulting in regu…

• FDA approval · 2018-04-12
  FDA Approved: EVEROLIMUS — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s Original Application for Everolimus, establishing a generic version of the branded drug. The a…

• FDA approval · 2018-03-09
  FDA Approved: OCTREOTIDE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for octreotide acetate from Fresenius Kabi USA, LLC.

• 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 · 2016-10-12
  FDA Approved: ZORTRESS — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for ZORTRESS (everolimus) submitted by Novartis Pharmaceuticals Corporation. The action likely a…

• FDA approval · 2015-11-02
  FDA Approved: SOMATULINE DEPOT — Supplemental Application (Ipsen Biopharmaceuticals, Inc.)

  The FDA approved a supplemental application for Somatuline Depot (lanreotide acetate) submitted by Ipsen Biopharmaceuticals, Inc.