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Wyeth’s lowest Prempro formulation

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Wyeth will launch its lowest dose of Prempro (0.3 mg conjugated estrogens/1.5 mg medroxyprogesterone) late in the year following validation of manufacturing procedures. FDA approved the lower dose hormone replacement therapy June 4 for treatment of moderate to severe menopausal vasomotor symptoms and for postmenopausal osteoporosis prevention. The approval follows FDA's post-Women's Health Initiative recommendations that patients receive the lowest dose of HRT for the shortest amount of time (1Pharmaceutical Approvals Monthly May 1, 2003, In Brief). The agency simultaneously approved Prempro 0.45 /1.5 for the osteoporosis indication. Previously, only higher Prempro doses (0.625/2.5 and 0.625/5) were approved for osteoporosis preventio

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