In Brief: Wyeth-Ayerst Premarin

Executive Summary

Wyeth-Ayerst Premarin: Duramed files citizen's petition with FDA July 31 requesting that the agency declare Premarin (conjugated estrogens) "misbranded" because each active ingredient is not identified in labeling. The generics firm asks FDA to withdraw Wyeth's conjugated estrogens NDAs if labeling is not corrected and requests that no new indications be approved until Premarin is fully characterized. FDA determined May 5 that it would not approve generic versions of Premarin until the active ingredients are sufficiently defined ("The Pink Sheet" May 12, p. 3)...