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Amneal Pharmaceuticals announces FDA approval for OTC Naloxone HCI
The Fly

Amneal Pharmaceuticals announces FDA approval for OTC Naloxone HCI

Amneal Pharmaceuticals announced the availability of Over the Counter, or OTC, Naloxone Hydrochloride, or Naloxone HCI, Nasal Spray, USP, 4mg, following Abbreviated New Drug Application, or ANDA, approval from the FDA. Amneal’s Naloxone HCI Nasal Spray, manufactured in the U.S., is a generic equivalent to OTC Narcan HCI Nasal Spray, a medication that is widely used to help treat drug overdose from opioids, including heroin, fentanyl and prescription opioid medications.

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