Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats growth failure due to inadequate secretion of endogenous growth hormone (GH)…. Sold as Humatrope, Saizen, Bio-Tropin, Zomacton, Nutropin and 11 more. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 10 applications for Somatropin (sold as Humatrope, Saizen, Bio-Tropin and others), first approved Oct 16, 1986, with 38 new uses approved and 0 published complete response letters.
First approved: Oct 16, 1986
Applications: 10
New uses approved: 38
Complete response letters: 0
Medicare spending, 2025: $189M
First approved in the EU: Feb 15, 2001
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Genotropin TCDrugs with a new indication and a new dosage for the improvement of body composition in patients with Prader-Willi syndrome. · Pfizer Japan Inc. · Dec 22, 2023
Growject S.C.Drugs with a new indication for the treatment of short stature in SHOX deficiency prior to epiphyseal closure. · JCR Pharmaceuticals Co., Ltd. · Jun 26, 2023
Norditropin FlexProDrugs with a new additional indication for the treatment of short stature associated with Noonan syndrome with no epiphyseal closure. · Novo Nordisk Pharma Ltd. · Nov 30, 2017
Growject BCDrugs with a new additional indication and a new dosage for the treatment of SGA (small-for- gestational age) dwarfism not associated with epiphyseal closure. · JCR Pharmaceuticals Co., Ltd. · Aug 24, 2012
GrowjectDrugs with a new additional indication and a new dosage for the treatment of adult growth hormone deficiency (for use only in severe cases). · JCR Pharmaceuticals Co., Ltd. · Jul 7, 2009
Somatropin BS S.C., new approvalFollow-on biologics indicated for the treatment of growth disturbance due to growth hormone deficiency before epiphyseal closure and growth disturbance… · Sandoz K.K. · Jun 22, 2009
Norditropin SDrugs with a new additional indication and a new dosage for the treatment of dwarfism with no epiphyseal closure in patients born small for gestational age… · Novo Nordisk Pharma Ltd. · Jun 17, 2009
Norditropin SDrugs with a new additional indication and a new dosage for the treatment of adult growth hormone deficiency (for use only in severe cases). · Novo Nordisk Pharma Ltd. · Apr 22, 2009
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Lilly
Pharmacia
Sandoz