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The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / Submissions and Approvals
Lawmakers Blast FDA’s Decision to Approve Opioid Zohydro ER
Dec. 6, 2013
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.
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