Food and Drug Administration

Gastrointestinal Drugs Advisory Committee

June 25, 2003

Briefing Information

Serostim [somatropin (rDNA orgin) for injection]

Cover Memorandum From Alice Kacuba, R.N. for Dr. Robert L. Justice, M.D., M.S., FDA (HTM) (PDF) (Word)

Medical Officer Review of NDA 21-597: Serostim® [somatropin (rDNA origin) for injection] Treatment of Short Bowel Syndrome, FDA (HTM) (PDF) (Word)

Statistical Review and Evaluation - Clinical Studies, FDA (HTM) (PDF) (Word)