Wednesday, March 29, 2023

FDA approves over-the-counter use of opioid overdose reversal drug Naloxone as a Nasal Spray

Good news! What took so long! Should have been done years ago!

The FDA slow worked this at least since 2019!

The senile and demented 46th President and his largely incompetent administration with its as many as possible firsts and implicit gender quota has even the audacity to blame the manufactures for the long delay!


"Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Today’s action paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.  ...
The FDA has taken a series of measures to help facilitate access to naloxone products. In November 2022, the agency announced its preliminary assessment that certain naloxone products, such as the one ultimately approved today, have the potential to be safe and effective for over-the-counter use and encouraged sponsors to submit applications for approval of OTC naloxone products. The agency previously announced in 2019 that it had designed, tested, and validated a model naloxone Drug Facts Label (DFL) with easy-to-understand pictograms on how to use the drug to encourage manufacturers to pursue approval of OTC naloxone products. ..."

FDA approves over-the-counter use of opioid overdose reversal drug Narcan | Just The News More than 100,000 people in America died from drug overdoses last year.

FDA NEWS RELEASE FDA Approves First Over-the-Counter Naloxone Nasal Spray Agency Continues to Take Critical Steps to Reduce Drug Overdose Deaths Being Driven Primarily by Illicit Opioids

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