Agency signals assurance about making naloxone available OTC, so much so that firms with approved NDAs for Rx products should prepare for an all-nonprescription market. After offering model label to spur OTC switch NDAs, FDA notice about OTC assessment is second unprecedented step on its naloxone journey since opioid crisis declared a public health emergency in 2017.
The US Food and Drug Administration took a second unprecedented step in spurring development of OTC naloxone products by publishing a notice identifying data and other information needed in new drug applications for nonprescription access.
In a notice published on 15 November requesting comments, the agency signals that it is becoming assured about making...