Noonan Syndrome

• 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…

• CLINICAL_TRIALS trial_result · 2010-10-05
  Clinical Trial Update: Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's Syndrome [Phase 3]

  Phase 3 trial evaluating MAXOMAT for growth in young children with Noonan syndrome has completed. The sponsor is Sanofi.

• 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.

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• 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.

• CLINICAL_TRIALS trial_result · 2007-03-30
  Clinical Trial Update: Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome [Phase 2]

  A Phase 2 trial evaluating a combination of recombinant human insulin-like growth factor-1 and recombinant human insulin-like growth factor …

• 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.