Health
FDA grants expedited review of marketed overdose drugs
The Food and Drug Administration (FDA) is rushing to review new over-the-counter opioid overdose antagonists.
Non-profit pharmaceutical company Harm Reduction Therapeutics said on Monday: release The FDA granted priority review to a new drug application for RiVive, a naloxone nasal spray for emergency overdose treatment.
Naloxone is a drug given to reverse the effects of a suspected opioid overdose.With brand names like Narcan, Naloxone usually available It is sold behind the counter without a prescription.
According to Michael Hufford, co-founder and CEO of Harm Reduction Therapeutics, drug filing progress shows that “the public health landscape is beginning to evolve” and low-cost over-the-counter drugs “hopefully become a reality.” It indicates that it is set to be a thing.
However, it will still be some time before the FDA calls RiVive and an approval decision is expected by the end of April 2023.
Hoping for a green light from the agency, the nonprofit says it has signed a commercial supply agreement and is preparing to launch the drug in the United States in 2024.
FDA also earlier this month Grant of priority review Narcan’s maker, Emergent BioSolutions Inc., plans to approve a two-dose naloxone nasal spray in March 2023.
researchers and pharmaceutical companies push As the country deals with the growing opioid epidemic, medicines will be accessible without a prescription and without talking to the pharmacist behind the counter.
Opioids are the leading cause of drug overdose deaths in the United States. According to the CDC.
News of the latest push to fast track approval first reported By The Wall Street Journal.
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Sources 2/ https://thehill.com/policy/healthcare/3788913-fda-grants-fast-track-review-for-over-the-counter-overdose-drug/ The mention sources can contact us to remove/changing this article |
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