Food and Drug Administration

Endocrinologic & Metabolic Drugs Advisory Committee

June 10, 2003

Briefing Information

Humatrope® (somatropin [rDNA orgin] for injection)


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Humatrope® (somatropin [rDNA orgin] for injection) for Non-Growth Hormone Deficient Short Stature (HTM) (PDF) (Word)

Humatrope® (somatropin [rDNA orgin], Table of Contents, FDA (HTM) (PDF) (Word)

Clinical Review, FDA (HTM) (PDF) (Word)

Statistical Reveiw, FDA (HTM) (PDF) (Word)

Bibliography (HTM) (PDF) (Word)

Addendum to the Statistical Review (HTM) (PDF) (Word)