Acromegaly

• FDA approval · 2020-08-21
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for Bromocriptine Mesylate submitted by Padagis US LLC.

• FDA approval · 2020-06-26
  FDA Approved: MYCAPSSA — Original Application (Chiesi USA, Inc.)

  The FDA approved MYCAPSSA, an oral formulation of octreotide from Chiesi USA, representing the original approval of an oral octreotide produ…

• 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 · 2019-12-13
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a Supplemental Application for Bromocriptine Mesylate by ANI Pharmaceuticals, Inc. The provided excerpt does not specify a new …

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• FDA approval · 2019-09-24
  FDA Approved: SOMAVERT — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental application for Somavert (pegvisomant) submitted by Pharmacia & Upjohn Company LLC.

• FDA approval · 2019-09-19
  FDA Approved: SOMAVERT — Supplemental Application (Pharmacia & Upjohn Company LLC)

  FDA approved a supplemental application for Somavert (pegvisomant) submitted by Pharmacia & Upjohn Company LLC. Somavert is used to treat ac…

• 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 · 2019-08-16
  FDA Approved: SOMAVERT — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental application for Somavert (pegvisomant) submitted by Pharmacia & Upjohn Company LLC. This action updates the …

• 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 · 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 · 2019-01-29
  FDA Approved: SIGNIFOR — Supplemental Application (Recordati Rare Diseases, Inc.)

  The FDA approved a supplemental application for Signifor (pasireotide) submitted by Recordati Rare Diseases, Inc. This action expands the dr…

• 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 · 2018-08-27
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Octreotide acetate from Hikma Pharmaceuticals USA.

• 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 · 2018-02-22
  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 · 2017-07-10
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Sagent Pharmaceuticals)

  FDA approves a supplemental application for Octreotide Acetate submitted by Sagent Pharmaceuticals.

• FDA approval · 2017-06-27
  FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Meitheal Pharmaceuticals, Inc.)

  The FDA approved Meitheal Pharmaceuticals' supplemental application for octreotide acetate. This approval authorizes a generic octreotide ac…

• 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 · 2016-05-20
  FDA Approved: SANDOSTATIN LAR DEPOT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Sandostatin LAR Depot (octreotide acetate) by Novartis, resulting in changes to the product …

• FDA approval · 2016-04-22
  FDA Approved: SOMAVERT — Supplemental Application (Pharmacia & Upjohn Company LLC)

  FDA approved a supplemental application for Somavert (pegvisomant) submitted by Pharmacia & Upjohn Company LLC.

• FDA approval · 2016-02-22
  FDA Approved: SOMAVERT — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental application for Somavert (pegvisomant) submitted by Pharmacia & Upjohn Company LLC.

• FDA approval · 2016-01-11
  FDA Approved: SOMAVERT — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental application for Somavert (pegvisomant) submitted by Pharmacia & Upjohn Company LLC.

• CLINICAL_TRIALS approval · 2015-12-29
  Clinical Trial Update: An Open-label, Multi-center, Expanded Treatment Protocol of Pasireotide LAR in Patients With Acromegaly

  An open-label, multi-center expansion of Pasireotide LAR treatment for acromegaly is discussed, with the product listed as approved for mark…

• 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.