Business · 11/06/2013
FDA Clears Way for Flurandrenolide Ointment to be Approved via Abbreviated New Drug Applications
The FDA has determined that CORDRAN (flurandrenolide) Ointment USP, 0.025% and 0.05%, were not withdrawn from sale due to safety or effectiveness concerns, paving the way for potential approval via abbreviated new drug applications.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →