FDA BRIEFING DOCUMENT

 

ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE

 

NDA 19-640/S-033

HUMATROPEŽ

(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.