In order to approve the drug for sale, the FDA will need to impose restrictions to protect public safety.
The regulatory body found the drug met safety and efficacy targets, but a majority of members worried the drug, a hydrocodone bitartrate, would become a “drug of choice” for prescription pain killer addicts.
Bob Rappaport, MD, director of the FDA’s division of anesthesia, analgesia and addiction products tasked the regulators with deciding whether the decision was based on a marked difference between Zohydro and other similarly opioid-based drugs.
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