FDA tentatively OKs expanded label for Egalet's pain med Arymo ER; shares up 31% premarket [Seeking Alpha]
EGALET CORP COMMON (EGLT)
Last egalet corp common earnings: 8/8 06:02 am
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Source: Seeking Alpha
FDA tentatively OKs expanded label for Egalet's pain med Arymo ER; shares up 31% premarketNano cap Egalet (NASDAQ:EGLT) is up31% premarket on light volume in response to itsannouncement that the FDA has tentatively approved new labeling for opioid pain med ARYMO ER (morphine sulfate) extended-release tablets C-II.The new labeling will include data from a Category 2/3 intranasal human abuse potential study and an intranasal abuse-deterrent claim.Tentative approval means that the application was complete enough for full approval but patent issues need to be resolved. In this case, the date for patent exclusivity will expire on October 2, 2018.ARYMO ER incorporates the company'sGuardian Technology which uses injection molding to create a hard matrix designed to make the pill difficult to crush, grind, chew or dissolve. It also turns to gel when exposed to water.See all stocks on the move »
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