FDA Panel to Review Emergent’s Over-the-Counter Opioid Overdose Drug

[Epoch-Times-Bot]

FDA Panel to Review Emergent's Over-the-Counter Opioid Overdose Drug

The U.S. health regulator said on Tuesday its advisory panel will meet on Feb. 15 to review Emergent Biosolutions Inc.’s over-the-counter (OTC) nasal spray to treat suspected opioid overdoses.
Emergent is seeking the Food and Drug Administration’s (FDA) approval for the prescription-free sale of Narcan, its nasal spray form of the drug naloxone. Narcan is already cleared for the treatment of opioid overdose in the country.
Last month, the health agency accorded Narcan’s marketing application a priority review status, and is set to make its decision by March 29. The panel will assess the adequacy of data that supports the nonprescription use of the drug....

Source: FDA Panel to Review Emergent's Over-the-Counter Opioid Overdose Drug

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