Estrogens for Postpartum Breast Engorgement; Withdrawal of Approval of the Labeled Indication for Postpartum Breast Engorgement in Estrogen-Containing Drug Products; Final Order

摘要

The Food and Drug Administration (FDA) is withdrawing approval of estrogen-containing drugs insofar as they are indicated for use in postpartum breast engorgement. The basis for the action is that estrogens are not shown to be safe for that use.