FDA Approved: OMNITROPE — Supplemental Application (Sandoz Inc)

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Summary

The FDA approved a supplemental application for Omnitrope (somatropin) from Sandoz Inc, potentially expanding or updating the product’s labeling and indications…

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Diseases / indications

• Chronic Kidney Disease
• Growth Hormone Deficiency
• Idiopathic Short Stature
• Noonan Syndrome
• Prader-willi Syndrome
• Small For Gestational Age
• Turner Syndrome

Drugs mentioned

• OMNITROPE (somatropin)

Snippet

SUPPL AP for OMNITROPE (SOMATROPIN)