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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.
The FDA has a "priority review process" for drugs which compete with another drug whose price exceeds its value-based price. Congress could also grant the FDA the ability to change the exclusivity period for new drugs. [6] The FDA could also temporarily allow the import of drugs approved for sale outside the United States. [69]
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.
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The FDA just approved Neffy, a needle-free EpiPen alternative. Here's when it's hitting shelves—and allergists tell 'Women's Health' if they recommend it.
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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 ...
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 ...