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BRIEF-Egalet notified that FDA will not meet PDUFA goal data for ARYMO ER
October 13, 2016 / 10:17 PM / a year ago

BRIEF-Egalet notified that FDA will not meet PDUFA goal data for ARYMO ER

Oct 13 (Reuters) - Egalet Corp :

* Egalet notified that FDA will not meet PDUFA goal data for ARYMO ER

* Egalet Corp -FDA will not meet previously announced October 14 Prescription Drug User Fee Act (PDUFA) date for ARYMO ER

* Egalet - FDA has identified no particular issue with Co’s application for ARYMO ER and it is working on product label

* On ARYMO ER - FDA indicated that they need more time as they have done with other abuse-deterrent opioid NDA

* Egalet Corp - FDA confirms no additional scientific information or data is needed for application for ARYMO ER Source text for Eikon: Further company coverage:

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