Food and Drug Administration

Advisory Committee for Reproductive Health Drugs

September 29, 2003

Briefing Information

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

Introduction (HTM) (PDF) (Word)

Definitions (HTM) (PDF) (Word)

Human Gonadotropins: A Regulatory Perspective, Dr. Shelley Slaughter, MD, PhD, FDA (HTM) (PPT)

Bibliography (HTM) (PDF) (Word)

Pergonal® (Menotropins for Injection, USP) for Intramuscular Injection (PDF)

Metrodin® (Urofollitropin for Injection) for Intramuscular Injection (PDF)

Fertinex® (Urofollitropin for Injection, Purified) for Subcutaneous Injection (PDF)

Repronex® (Menotropins for Injection, USP) Package Insert (PDF)

Follistim® (Organon) (Follitropin Beta for Injection) for Subcutaneous and Intramuscular Use Only (PDF)

Gonal-F® (Serono) (Follitropin Alfa for Injection) for Subcutaneous Injection (PDF)