FDA Approved: NORDITROPIN — Supplemental Application (Novo Nordisk)

View source ↗

Summary

FDA approved a supplemental application for Norditropin (somatropin) from Novo Nordisk, indicating an approved update to the existing BLA.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

• Growth Failure Associated with Chronic Kidney Disease
• Growth Hormone Deficiency
• Idiopathic Short Stature
• Noonan Syndrome
• Prader-willi Syndrome
• Short Stature in Children Born Small For Gestational Age
• Shox Deficiency
• Turner Syndrome

Drugs mentioned

• Norditropin (somatropin)

Snippet

SUPPL AP for NORDITROPIN (SOMATROPIN)