FDA Denies Adapt Pharma’s Petition for Higher Standards to Approve Naloxone Generics

The FDA rejected Adapt Pharma’s request to raise the standards for the approval of naloxone generics, arguing that products will be reviewed on a case by case basis.

The citizen petition asked the FDA to establish an optimal initial dose for the narcotic overdose therapy, require pharmacokinetic exposure level studies for generic approvals, set standards for the rate at which the therapy can be removed from packaging for use in an emergency, and mandate human factors and label comprehension studies.

Additionally, the petition requested an FDA advisory committee meeting on the optimal dose for naloxone. The FDA convened two committees in October to discuss the adequate exposure levels to reverse an opioid overdose. No agreement was reached.