Egalet says FDA will not meet PDUFA goal data for ARYMO ER
Egalet Corporation announced that the U.S. Food and Drug Administration will not meet the previously announced October 14 prescription drug user fee act date for ARYMO ER. "Today we were informed that the FDA has identified no particular issue with our application for ARYMO ER and that the Agency is working on the product label," said Bob Radie, president and chief executive officer. "The FDA indicated that they need more time as they have done with other abuse-deterrent opioid NDAs, and confirmed that no additional scientific information or data is needed for our application. We will continue to work closely with the FDA to bring this important product to those living with chronic pain and the healthcare professionals who treat them."