Business · 18/11/2019
FDA Withdraws Approval of Fentanyl Transdermal Systems by Mayne Pharma and Actavis
The US Food and Drug Administration (FDA) has withdrawn the approval of two fentanyl transdermal systems, one by Mayne Pharma Group Ltd. and the other by Actavis Laboratories UT, Inc., following requests from both companies to withdraw their applications and waive a hearing.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →