Acromegaly

• FDA approval · 2011-02-10
  FDA Approved: OCTREOTIDE ACETATE — Original Application (Mylan Institutional LLC)

  The FDA approved the original ANDA for octreotide acetate from Mylan Institutional LLC. This marks the generic approval for this product.

• FDA approval · 2010-07-20
  FDA Approved: SOMAVERT — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental application for Somavert (pegvisomant) from Pharmacia & Upjohn Company LLC to update/expand its labeling.

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

  FDA approved a supplemental application for Octreotide acetate from Hikma Pharmaceuticals USA Inc., updating the regulatory status of the ge…

• 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.

• FDA approval · 2008-10-03
  FDA Approved: SOMAVERT — Supplemental Application (Pharmacia & Upjohn Company LLC)

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

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• FDA approval · 2008-10-01
  FDA Approved: BROMOCRIPTINE MESYLATE — Original Application (Padagis US LLC)

  FDA approved Padagis US LLC's original generic application for bromocriptine mesylate. This approval provides a generic version of bromocrip…

• FDA approval · 2008-08-18
  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 · 2008-07-30
  FDA Approved: BROMOCRIPTINE MESYLATE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved Zydus Pharmaceuticals USA Inc.'s generic bromocriptine mesylate product under an Original Application (ANDA). Bromocriptine mes…

• FDA approval · 2007-08-30
  FDA Approved: SOMATULINE DEPOT — Original Application (Ipsen Biopharmaceuticals, Inc.)

  The FDA approved Somatuline Depot (lanreotide acetate) under the Original Application for Ipsen Biopharmaceuticals.

• FDA approval · 2006-08-15
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approval of a supplemental application for a generic bromocriptine mesylate product by Mylan Pharmaceuticals Inc.