GENOTROPIN PRESERVATIVE FREE
Somatropin is a recombinant human growth hormone indicated for the treatment of growth failure and short stature in pediatric patients and growth hormone deficiency in adults. In children, it is used to treat conditions such as Noonan syndrome, Turner syndrome, Prader-Willi syndrome, and idiopathic short stature, as well as those born small for gestational age who fail to achieve catch-up growth. For adult patients, the therapy serves as a replacement for endogenous growth hormone in those with confirmed deficiency. The drug plays a critical therapeutic role in facilitating linear growth and managing metabolic functions associated with growth hormone levels.
How GENOTROPIN PRESERVATIVE FREE Works
Somatropin functions by binding to dimeric growth hormone receptors located on the cell membranes of target tissues. This interaction triggers intracellular signaling that induces the transcription and translation of growth-dependent proteins, including insulin-like growth factor 1 (IGF-1). These proteins stimulate the differentiation and proliferation of cartilage cells at the growth plates of long bones, which increases linear growth velocity. Additionally, somatropin exerts metabolic effects by increasing protein synthesis, stimulating hepatic glucose output, and promoting the breakdown of fats.
Details
- Status
- Prescription
- First Approved
- 1995-08-24
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
GENOTROPIN PRESERVATIVE FREE Approval History
What GENOTROPIN PRESERVATIVE FREE Treats
6 indicationsGENOTROPIN PRESERVATIVE FREE is approved for 6 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Growth Hormone Deficiency
- Short Stature
- Noonan Syndrome
- Turner Syndrome
- Small for Gestational Age
- Prader-Willi Syndrome
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GENOTROPIN PRESERVATIVE FREE FDA Label Details
ProIndications & Usage
FDA Label (PDF)NORDITROPIN is a recombinant human growth hormone indicated for: • Pediatric : Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Noonan syndrome, short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years, Idiopathic Short Stature (ISS), and growth failure due to Prader-Willi Syndrome • Adult : Replacement of endogenous GH in adults with growth hormone deficiency 1.1 Pediatric Patients NORDITROPIN is indicated for the ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.