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Wyeth Prempro Updated Label Submission Soon; HHS To Discuss WHI Results

Executive Summary

Wyeth expects to submit updated Prempro labeling reflecting the results of the Women's Health Initiative study on use of the hormone replacement therapy soon, the company said

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Premarin/Prempro Rxs Stabilize; Wyeth Predicts $300 Mil. Drop In 2nd Half

Wyeth is seeing some stabilization in the Premarin franchise despite a 40% drop in prescriptions for Prempro and a 15% decline in Premarin scripts since release of the Women's Health Initiative study results

Premarin/Prempro Rxs Stabilize; Wyeth Predicts $300 Mil. Drop In 2nd Half

Wyeth is seeing some stabilization in the Premarin franchise despite a 40% drop in prescriptions for Prempro and a 15% decline in Premarin scripts since release of the Women's Health Initiative study results

FDA estrogen guidances withdrawn

FDA withdrawing final clinical trial guidance on estrogen/progestin therapy: "Guidance for Clinical Evaluation of Combination Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal Women," agency says in Sept. 10 Federal Register notice. FDA is also pulling the draft labeling guidance "Labeling Guidance for Noncontraceptive Estrogen Drug Products: Prescribing Information for Healthcare Providers and Patient Labeling." The decision comes after the NIH Women's Health Initiative trial was halted due to an increased risk of breast cancer and cardiovascular events in patients on Wyeth's Prempro (1"The Pink Sheet" July 15, p. 11). FDA plans to hold a public meeting on the hormone therapy issue this fall (2"The Pink Sheet" Aug. 19, p. 11)...

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