Shares of Egalet Corp traded lower by more than 5 percent Monday morning after a scheduled meeting with the U.S. Food and Drug Administration (FDA) to discuss its delayed ARYMO ER therapy.
Egalet said in a press release that the FDA “has identified no particular issue with our application for ARYMO ER and that the Agency is working on the product label.” The company added, “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.”
