Last September, 19 patient advocacy groups went even further, demanding the resignation of the FDA’s then-commissioner, Margaret Hamburg. “The overall risk-benefit balance wasn’t such that it should have been approved.” Alexander joined dozens of health care agencies, consumer groups, and state and federal officials-including attorneys general from 28 states-calling for the FDA to reconsider. Caleb Alexander, a physician and co-director of the Center for Drug Safety and Effectiveness at Johns Hopkins Bloomberg School of Public Health. “Zohydro doesn’t serve a compelling clinical need,” says G. The FDA’s own advisory committee recommended against approving the new drug in an 11-2 vote, citing concerns about the drug’s potential for improper use.
Zohydro contains up to five times the hydrocodone used in popular short-acting formulations such as Vicodin. The agency contended that the drug was needed and useful, but its decision quickly drew sharp criticism. Food and Drug Administration approved the drug Zohydro, the first long-acting formulation of the opioid painkiller hydrocodone.
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