ALO – Here’s an excuse I haven’t seen before for withdrawing an NDA. The company says “certain issues” prevented the FDA from evaluating the NDA within the six-month window allotted for Priority Review and hence ALO will resubmit the NDA later.
Embeda is a formulation of morphine that contains embedded naltrexone. If a user crushes the capsule, the naltrexone is released and it supposedly averts a morphine-induced high, serving as a deterrent to abuse.
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