Food and Drug Administration

Advisory Committee for Reproductive Health Drugs

September 30, 2003

Briefing Information


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Table of Contents (HTM) (PDF) (Word)

Introduction (HTM) (PDF) (Word)

Medical Officer's Original Clinical Review (PDF)

Statistical Review and Evaluation - Clinical Studies (PDF)

Clinical Pharmacology Review (PDF)

Team Leader Review (PDF)

Luveris™ Clinical Review (HTM) (PDF) (Word)

Bibliography (HTM) (PDF) (Word)

Luveris® (Lutropin Alfa for Injection), Serono, Inc. (PDF)

Definitions for Severity Categories for Ovarian Hyperstimulation Syndrome (OHSS), Serono, Inc. (PDF)

Narratives for Serious Adverse Events, Serono, Inc. (PDF)

Bibliography, Serono, Inc. (PDF)