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It's designed to be used in emergencies when someone who is at least 66 pounds has an allergic reaction—including life-threatening reactions like anaphylaxis, per the FDA.
The first modern epinephrine autoinjector, the EpiPen, was invented in the mid-1970s at Survival Technology in Bethesda, Maryland, US by Sheldon Kaplan [11] [12] and was first approved for marketing by the FDA in 1987. [13] One of the people who helped in making the EpiPen was Richard B. Toren.
Drug price data from LMICs can be lacking, and in such situations, international medicine prices can be obtained from the International Medical Products Price Guide. Some countries use ERP for all drug pricing, and some just for new drugs that are on-patent. [8]: 300–303 In addition to prices, most products in the guide have a defined daily ...
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The decision comes at a time when the shortage has come under focus at the start of back-to-school season, and applies to specific lots of 0.3 milligram EpiPen products, after the regulator ...
[2] [30] [38] It is the first nasal spray for the treatment of anaphylaxis approved by the US Food and Drug Administration (FDA). [ 30 ] The approval of epinephrine nasal spray is based on four studies in 175 healthy adults, without anaphylaxis, that measured the epinephrine concentrations in the blood following administration of epinephrine ...
The U.S. health regulator has declined to approve a nasal spray that would have been the first needle-free emergency treatment for allergic reactions, a surprise decision that sent shares of its ...
In August 2021, the FDA and the CDC authorized the use of an additional mRNA vaccine dose for immunocompromised individuals. [318] [319] The authorization was extended to cover other specific groups in September 2021. [320] [321] [322] In October 2021, the FDA and the CDC authorized the use of either homologous or heterologous vaccine booster ...