Food and Drug Administration
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)