FDA accepts NDA for Arymo ER (morphine sulfate) extended-release- Egalet
Egalet Corporation announced that the FDA has accepted the new drug application (NDA) for Arymo ER (morphine sulfate) extended-release tablets. Arymo ER is being developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The FDA Prescription Drug User Fee Act (PDUFA) goal date for a decision is 14 October 2016.
Comment: Egalet's proprietary Guardian Technology is a polymer matrix tablet technology that utilizes a novel manufacturing process, plastic injection molding, which results in tablets with controlled-release properties as well as physical and chemical features that have been demonstrated to resist both common and rigorous methods of manipulation.
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