Kaleo's Naloxone Auto-injector 10 mg received FDA approval and is intended for military personnel facing the potential threat of exposure to synthetic opioids on the battlefield.
Kaleo’s Naloxone Auto-injector 10 mg received FDA approval and is intended for military personnel facing the potential threat of exposure to synthetic opioids on the battlefield.
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Kaléo will pay the United States $12.7 million to resolve allegations that Kaléo caused the submission of false claims for the drug Evzio, an injectable form of naloxone hydrochloride for opioid overdose.
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Kaleo Inc has discontinued its naloxone hydrochloride injection product Evzio and its authorized generic, according to industry reports.
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Kaleo will offer an Evzio generic (naloxone HCl injection) at a list price of $178 per carton (two auto-injectors per carton).
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The FDA has approved the Auvi-Q 0.1 mg — the first and only epinephrine auto-injector (EAI) with a needle length and dose specifically designed for infants and small children.
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Kaleo, the company that makes a naloxone auto-injector called Evzio, is coming under fire for raising the price of a two-pack from $690 to $4500Â since 2014.
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Kaleo has launched US commercial availability of Evzio for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
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The US FDA approved Evzio (naloxone hydrochloride injection) for the emergency treatment of known or suspected opioid overdose by for immediate administration by family members or caregivers for suspected opioid overdose.
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