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Wyeth’s second low-dose HRT

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Wyeth plans to launch low-dose Premarin (.45 mg estrogens) this summer along with the recently approved low-dose PremPro (.45 mg estrogens/1.5 mg medroxyprogesterone). FDA cleared the Premarin formulation April 25; low-dose PremPro was approved March 12 (1Pharmaceutical Approvals Monthly April 1, In Brief). The product's estrogen content is 28% less than the standard .625 mg dose, which Wyeth says allows for "better individualization of therapy, particularly for new patients." The firm hopes that the low-dose products will allay concerns stemming from the Women's Health Initiative stud

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