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Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. The timeline for availability and price of this OTC product is determined by the manufacturer. The approval of OTC Narcan nasal spray will require a change in the labeling for the currently approved 4 mg generic naloxone nasal spray products that rely on Narcan as their reference listed drug product. The use of Narcan nasal spray in individuals who are opioid dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate tachycardia, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure. The agency previously announced in 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. The FDA, an agency within the U. For Immediate Release: March 29,

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