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Amenorrhea

U.S. FDA Approves Oral Progesterone Prometrium

Published in Women's Health Weekly, June 1st, 1998

Solvay Pharmaceuticals, Inc., announced that the United States Food and Drug Administration (FDA) has approved the company's PrometriumR (Progesterone, USP) Capsules for the treatment of secondary amenorrhea.

Prometrium is the first oral dosage form of micronized progesterone. It is synthesized from yams and is structurally identical to the natural progesterone found in a woman's body. Micronization increases the absorption of progesterone. Micronized progesterone was used in the National Institutes of Health-sponsored PEPI (Post-menopausal Estrogen/Progestin Intervention) study. PEPI was a three-year, multicenter, double-blind, placebo-controlled trial...

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