FDA Fast-Tracks Approval of Overdose Reversal Drug for OTC Use

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FDA Fast-Tracks Approval of Overdose Reversal Drug for OTC Use
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An inexpensive overdose-reversal drug in nasal spray form is being fast-tracked by the FDA for consideration to be sold over-the-counter.

reported. Harm Reduction Therapeutics says it will also give away some of its product.

Earlier this month, Emergent BioSolutions, the maker of the widely known naloxone product Narcan, announced the FDA was fast-tracking its product in an over-the-counter nasal-spray form. The price has not been announced. The injectable version of Narcan costs as low as $37, according to the website GoodRx.without a prescription but is sold behind the counter in pharmacies.

Emergent BioSolutions previously said its nasal spray may receive approval by the end of March. Harm Reduction Therapeutics expects the FDA to decide whether to approve RiVive by April 28.Harm Reduction Therapeutics Inc.: “Harm Reduction Therapeutics' New Drug Application for RiVive Over-the-Counter Naloxone Nasal Spray Accepted and Granted Priority Review by FDA.”: “FDA Fast-Tracks Review of Overdose Drug Naloxone for Use Without Prescription.

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