NUTROPIN AQ NUSPIN
Nutropin AQ NuSpin (somatropin) is a recombinant human growth hormone indicated for the treatment of growth failure and growth hormone deficiency in pediatric and adult patients. In children, the therapy is used to address growth failure associated with genetic conditions such as Noonan syndrome, Turner syndrome, and Prader-Willi syndrome, as well as idiopathic short stature and those born small for gestational age. For adults, the drug serves as a replacement for endogenous growth hormone in patients with confirmed deficiency. The medication functions as a hormonal replacement to facilitate linear growth and regulate various metabolic processes.
How NUTROPIN AQ NUSPIN Works
Somatropin works by binding to dimeric growth hormone receptors located on the cell membranes of target tissues. This interaction triggers intracellular signaling and the subsequent production of growth-dependent proteins, including insulin-like growth factor-1 (IGF-1). These proteins stimulate the differentiation and proliferation of cartilage cells within the growth plates of long bones, which increases linear growth velocity in pediatric patients. Beyond skeletal growth, the drug also influences metabolism by promoting protein synthesis, lipolysis, and hepatic glucose output.
Details
- Status
- Prescription
- First Approved
- 1995-12-29
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
NUTROPIN AQ NUSPIN Approval History
What NUTROPIN AQ NUSPIN Treats
6 indicationsNUTROPIN AQ NUSPIN 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.
NUTROPIN AQ NUSPIN 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.