Business · 14/08/2001Updated: 10/17/2026 · 1 min read
FDA Proposes Withdrawal of Approval for Phenylpropanolamine-Based Drugs
Summary
The FDA is proposing to withdraw approval of 16 new drug applications and 8 abbreviated new drug applications for prescription and over-the-counter drugs containing phenylpropanolamine, citing the increased risk of hemorrhagic stroke associated with the substance.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →