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An epinephrine autoinjector (or adrenaline autoinjector, also known by the trademark EpiPen) is a medical device for injecting a measured dose or doses of epinephrine (adrenaline) by means of autoinjector technology. It is most often used for the treatment of anaphylaxis. The first epinephrine autoinjector was brought to market in 1983.
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...
The commonly used epinephrine autoinjector delivers a 0.3 mg epinephrine injection (0.3 mL, 1:1000). [citation needed] It is indicated in the emergency treatment of allergic reactions, including anaphylaxis to stings, contrast agents, medicines, or people with a history of anaphylactic reactions to known triggers.
ARS Pharmaceuticals said that for people with commercial insurance that covers the drug, the price out of pocket would be no more than $25 for two single-use devices, via a co-pay program.
On Monday, the FDA accepted Eisai Co., Ltd. (OTC:ESALY) and Biogen Inc’s (NASDAQ:BIIB) Biologics License Application (BLA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector (SC-AI) for ...
U.S. health officials Saturday agreed to allow emergency use of a second antibody drug to help the immune system fight COVID-19.
An autoinjector (or auto-injector) is a medical device for injection of a premeasured dose of a particular drug. Most autoinjectors are one-use, disposable, spring-loaded syringes (prefilled syringes). By design, autoinjectors are easy to use and are intended for self-administration by patients, administration by untrained personnel, or easy ...
In August 2024, the FDA approved a nalmefene hydrochloride auto-injector (Zurnai) for the emergency treatment of known or suspected opioid overdose in people aged twelve years of age and older. [ 5 ] [ 35 ] The FDA granted the application for the nalmefene hydrochloride auto-injector fast track and priority review designations. [ 35 ]