GastrointestinalDrugsAdvisoryCommitteeJune25,2003.ppt

SBS AC Presentation Serono, Inc. Gastrointestinal DrugsAdvisory CommitteeJune 25, 2003 Pamela Williamson Joyce, RAC Vice President, Regulatory Affairs Quality Assurance – US Serono, Inc. Proposed Indication Serostim? [somatropin (rDNA origin) for injection] is indicated for the treatment of Short Bowel Syndrome in patients receiving specialized nutritional support. Serostim therapy should be used in conjunction with optimal management of Short Bowel Syndrome. Agenda Serostim?[somatropin (rDNA origin) for injection] Growth hormone produced by recombinant DNA technology Lyophilized in 4 m