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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.
(Reuters) - The U.S. Food and Drug Administration (FDA) on Friday said it had identified the recall of B. Braun Medical Inc's medicine-delivering pump system as most serious.
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.
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Those profits were also due in part to Mylan's continually raising the price of EpiPens starting in 2009; in 2009 the wholesale price of two EpiPens was about $100, by July 2013 the price was about $265, in May 2015 it was around $461, and in May 2016 the price rose again to around $609, [90] around a 500% jump from the price in 2009. [94]
Cardiac valvular disease, pulmonary hypertension, cardiac fibrosis; [3] [23] re-approved in June 2020 for the treatment of seizures associated with Dravet syndrome, under FDA orphan drug rules. Fenoterol: 1990 New Zealand Asthma mortality. [3] Feprazone: 1984 Germany, UK Cutaneous reaction, multiorgan toxicity. [3] Fipexide: 1991 France ...
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 ...
On May 10, 2021, the FDA granted emergency use authorization for the Pfizer vaccine for use on adolescents aged 12–15, making the United States the second country in the world, after Canada, to do so. [135] On May 12, Director of the CDC Rochelle Walensky approved the recommendation. [136]