Business · 20/02/2014Updated: 10/17/2026 · 1 min read
FDA Withdraws Approval of 13 New Drug Applications and 7 Abbreviated New Drug Applications for Phenylpropanolamine Products
Summary
The US Food and Drug Administration (FDA) has withdrawn approval of 13 new drug applications and 7 abbreviated new drug applications for products containing phenylpropanolamine, citing an increased risk of hemorrhagic stroke associated with its use.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →