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FDA approves naloxone injection to counteract opioid overdoses

Action: FDA has approved ZIMHI (naloxone hydrochloride) injection as an additional option to treat opioid overdose. ZIMHI is administered using a single-dose, prefilled syringe that delivers 5 milligrams (mg) of naloxone hydrochloride solution through intramuscular (in the muscle) or subcutaneous (under the skin) injection.

FDA has previously approved injectable naloxone hydrochloride products in 0.4 mg and 2 mg doses under the trade name, NARCAN.

Disease or Condition: Naloxone is a medicine that can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If naloxone is administered quickly, it can counter the opioid overdose effects, usually within minutes. A 5 mg/0.5 mL prefilled syringe of naloxone provides an additional option in the treatment of opioid overdoses.

Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illegal drug heroin.

Opioid-related overdose deaths—driven partly by prescription drug overdoses—are one of the leading causes of death in the United States. When someone overdoses on an opioid, it can be difficult to awaken the person, and breathing may become shallow or stop – leading to death if there is no medical intervention.

Effectiveness: ZIMHI received approval through the 505(b)(2) approval pathway under the Federal Food, Drug, and Cosmetic Act. A new drug application submitted through this pathway may rely on the FDA’s finding that a previously approved drug is safe and effective or on published literature to support the safety and/or effectiveness of the proposed product, if such reliance is scientifically justified. In this case, the manufacturer submitted a 505(b)(2) application that relied, in part, on the FDA’s finding of safety and effectiveness for naloxone hydrochloride (NARCAN injection) to support approval. The applicant demonstrated that reliance on the FDA’s finding of safety and effectiveness for Narcan was scientifically justified and provided ZIMHI-specific pharmacokinetic data to establish the drug’s safety and efficacy for its approved use.

Safety Information: Use of naloxone in patients who are opioid-dependent may result in opioid withdrawal, characterized by rapid onset of severe body aches, vomiting, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps (piloerection), sweating, yawning, nausea, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.



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