Phenylpropanolamine; Proposal to Withdraw Approval of New Drug Applications and Abbreviated New Drug Applications; Opportunity for a Hearing

概要

The Food and Drug Administration (FDA) is proposing to withdraw approval of 16 new drug applications (NDAs) and 8 abbreviated new drug applications (ANDAs). These are the approved applications for prescription and over-the-counter (OTC) drug products containing phenylpropanolamine. FDA is offering the holders of the applications an opportunity for a hearing on the proposal. All other drug products containing phenylpropanolamine that are considered new drugs (e.g., extended-release products and any prescription product) are also subject to this notice. FDA is taking this action because of the association of phenylpropanolamine with increased risk of hemorrhagic stroke.