NORDITROPIN FLEXPRO
Norditropin (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, it is used to treat growth failure caused by inadequate endogenous growth hormone secretion, Prader-Willi syndrome, and short stature associated with Noonan syndrome, Turner syndrome, or being born small for gestational age. It is also indicated for pediatric patients with idiopathic short stature who are unlikely to reach a normal adult height. In adults, the drug serves as a replacement for endogenous growth hormone in those with growth hormone deficiency.
How NORDITROPIN FLEXPRO Works
Somatropin binds to dimeric growth hormone receptors on the cell membranes of target tissues, triggering intracellular signal transduction. This interaction induces the production of growth hormone-dependent proteins, such as IGF-1, which mediate various tissue and metabolic effects. In pediatric patients, the drug stimulates skeletal growth by acting on the growth plates of long bones and increasing cellular protein synthesis. It also regulates metabolic processes, including lipolysis, protein synthesis, and hepatic glucose output.
Details
- Status
- Prescription
- First Approved
- 2000-06-20
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
NORDITROPIN FLEXPRO Approval History
What NORDITROPIN FLEXPRO Treats
6 indicationsNORDITROPIN FLEXPRO is approved for 6 conditions since its original approval in 2000. 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.
NORDITROPIN FLEXPRO 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.