FDA BRIEFING DOCUMENT

ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE

NDA 19-640/S-033

HUMATROPE®

(somatropin [rDNA origin] for injection)

JUNE 10, 2003

TABLE OF CONTENTS

¨ CLINICAL REVIEW

¨ STATISTICAL REVIEW

¨ SELECTED REFERENCES

¨ American Academy of Pediatrics: Considerations related to the use of recombinant human growth hormone in children. Pediatrics 1997; 99: 122-9.

¨ Cuttler L et al. Short stature and growth hormone therapy - A national study of physician recommendations. JAMA 1996; 276:

531-37.

¨ Oberfield, SE, 1999. Editorial: Growth hormone use in normal, short children - A plea for reason. New England Journal Of Medicine 340: 557-559.