Gastroenteropancreatic Neuroendocrine Tumor

• FDA approval · 2024-10-25
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Gland Pharma Limited)

  FDA approved a supplemental application for Octreotide acetate submitted by Gland Pharma Limited.

• 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 · 2024-07-09
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for octreotide acetate (ANDA 203765) submitted by Heritage Pharmaceuticals d/b/a Avet Pharmaceut…

• FDA approval · 2024-05-21
  FDA Approved: LANREOTIDE ACETATE — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s original application for lanreotide acetate (lanreotide) to treat acromegaly and gastroenteropancreatic ne…

• FDA approval · 2023-12-05
  FDA Approved: OCTREOTIDE ACETATE — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved OCTREOTIDE ACETATE as an original application, enabling a Teva-manufactured generic octreotide acetate.

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• FDA approval · 2023-07-27
  FDA Approved: GA-68-DOTATOC — Supplemental Application (UIHC P E T Imaging Center)

  The FDA approved a supplemental application for GA-68-DOTATOC (edotreotide gallium-68) from the UIHC PET Imaging Center to use this radiopha…

• 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 · 2023-03-07
  FDA Approved: LUTATHERA — Supplemental Application (Advanced Accelerator Applications USA, Inc)

  FDA approved a supplemental application for LUTATHERA (lutetium Lu-177 dotatate) submitted by Advanced Accelerator Applications USA, Inc. Th…

• FDA approval · 2023-02-21
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for octreotide acetate by Mylan Institutional LLC under ANDA 079198, granting a supplemental approva…

• FDA approval · 2022-06-06
  FDA Approved: LUTATHERA — Supplemental Application (Advanced Accelerator Applications USA, Inc)

  FDA approves a supplemental application for LUTATHERA (Lutetium Lu-177 dotatate) filed by Advanced Accelerator Applications USA, Inc.

• FDA approval · 2021-12-17
  FDA Approved: LANREOTIDE ACETATE — Original Application (Cipla USA Inc.)

  The FDA approved lanreotide acetate from Cipla USA Inc. as an original application, providing a generic option for the somatostatin analog u…

• FDA approval · 2020-05-29
  FDA Approved: LUTATHERA — Supplemental Application (Advanced Accelerator Applications USA, Inc)

  The FDA approved a supplemental application for LUTATHERA (lutetium Lu-177 dotatate) from Advanced Accelerator Applications USA, Inc., grant…

• FDA approval · 2019-09-05
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for octreotide acetate submitted by Mylan Institutional LLC (ANDA079198). This action constitutes a …

• FDA approval · 2019-04-11
  FDA Approved: SOMATULINE DEPOT — Supplemental Application (Ipsen Biopharmaceuticals, Inc.)

  This FDA document indicates approval of a supplemental application for Somatuline Depot (lanreotide acetate) by Ipsen Biopharmaceuticals, In…

• 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 · 2016-07-22
  FDA Approved: SANDOSTATIN LAR DEPOT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Sandostatin LAR Depot (octreotide acetate) by Novartis Pharmaceuticals Corporation, resulting in…

• 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.

• FDA approval · 2015-06-01
  FDA Approved: SOMATULINE DEPOT — Supplemental Application (Ipsen Biopharmaceuticals, Inc.)

  The FDA approved a supplemental application for Somatuline Depot (lanreotide acetate) filed by Ipsen Biopharmaceuticals, Inc., updating the …

• FDA approval · 2014-12-22
  FDA Approved: SOMATULINE DEPOT — Supplemental Application (Ipsen Biopharmaceuticals, Inc.)

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

• FDA approval · 2012-09-12
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves a supplemental application for octreotide acetate (ANDA) by Hikma Pharmaceuticals USA Inc. The approval updates the labeling or…

• FDA approval · 2009-03-03
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for octreotide acetate submitted by Hikma Pharmaceuticals USA Inc., under the ANDA pathway.