Food and Drug Administration

Endocrinologic and Metabolic Drugs Advisory Committee

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)


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)