Food and Drug Administration
October 7, 2003
Briefing Information
Title Page (PDF)
Division Memorandum (HTM) (PDF) (Word)
Attachment I
FDA-Approved Prescribing Information for PREMPRO™ PREMPHASE® (PDF)
Attachment II
NHLB/WHI Briefing Document for the October 7, 2003 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee, Food and Drug Administration (HTM) (PDF) (Word)
Disclaimer
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.
Wyeth Pharmaceuticals Background Package
Hormone Therapy in Selected Postmenopausal Women at Risk for Osteoporosis (HTM) (PDF) (Word)