A group of lawmakers wants the FDA to strip Zogenix’s opioid painkiller Zohydro ER of its approval until the company creates an abuse-deterrent formulation of the product. Zohydro ER (hydrocodone bitartrate extended-release capsules) was approved recently as a single-entity hydrocodone Schedule II controlled substance with instructive labeling and indications for use, which the agency now requires for all extended release/long acting analgesics.
Drug Industry Daily