FDA says it won't meet PDUFA goal date for Egalet's Arymo ER

14 October 2016

The US Food and Drug Administration has advised specialty drugmaker Egalet (Nasdaq: EGLT) that it will not meet the previously announced October 14 prescription drug user fee act (PDUFA) date for the company’s Arymo ER (morphine sulfate).

Having shown a near 1.5% rise to $7.52 in normal trading yesterday, after hours Egalet’s shares fell 8.1% to $6.91. No revised date for an FDA decision has been given.

"Today we were informed that the FDA has identified no particular issue with our application for Arymo ER and that th Choosee Agency is working on the product label," said Bob Radie, president and chief executive.

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