Noonan Syndrome

• FDA approval · 2025-07-09
  FDA Approved: OMNITROPE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for OMNITROPE (somatropin) submitted by Sandoz Inc.

• FDA approval · 2020-01-08
  FDA Approved: GENOTROPIN — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved Genotropin (somatropin) via a supplemental application submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2016-06-23
  FDA Approved: NORDITROPIN — Supplemental Application (Novo Nordisk)

  FDA approves a supplemental application for Norditropin (somatropin) from Novo Nordisk, indicating changes to labeling and/or indications.

• FDA approval · 2016-02-26
  FDA Approved: NUTROPIN AQ NUSPIN 10 — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Nutropin AQ Nuspin 10 (somatropin) from Genentech, Inc., updating/expanding the product’s approv…

• FDA approval · 2013-04-04
  FDA Approved: OMNITROPE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Omnitrope (somatropin) from Sandoz Inc, potentially expanding or updating the product’s labe…

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• FDA approval · 2010-02-02
  FDA Approved: GENOTROPIN — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Genotropin (somatropin) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2007-09-20
  FDA Approved: NORDITROPIN — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for Norditropin (somatropin) from Novo Nordisk, indicating an approved update to the existing BLA.

• FDA approval · 2006-10-26
  FDA Approved: HUMATROPE — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for HUMATROPE (somatropin) submitted by Eli Lilly and Company.