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Epinephrine autoinjector

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664:'s generic competitor was rejected by the FDA in March 2016. By the first half of 2015, sales of EpiPen accounted for 40% of Mylan's profit. Those profits were also due in part to Mylan's continually raising the price of EpiPens starting in 2009: in 2007, the wholesale price of two EpiPens was about $ 100; the price was about the same in 2009; 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, around a 500% jump from the price in 2009. The last price increase sparked widespread outrage in the late summer as parents prepared to send their children back to school and went to pharmacies to get new EpiPens. Some Americans responded to the high price by buying EpiPens online from pharmacies outside the US, forgoing new EpiPens and relying on their expired EpiPen, or forgoing an autoinjector altogether and having their children carry pre-loaded syringes. 3803: 502:
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, around a 500% jump from the price in 2009. The cost of the drug and device to Mylan as of 2016 was about $ 35. In the summer of 2016, as parents prepared to send their children back to school and went to pharmacies to get new EpiPens, people began to express outrage at the cost of the EpiPen and Mylan was widely and harshly criticized. In September 2016, the New York State Attorney General began an investigation into Mylan's
123: 3437: 115: 174: 319: 3910: 4150: 149:. The injection may be repeated every 5 to 15 minutes if there is insufficient response. A second dose is needed in 16–35% of episodes with more than two doses rarely required; in around 80% of the cases where a second dose is administered, it is by a medical professional. It is not clear which are the people who might need a second injection at the outset. The intramuscular route is preferred over 3431: 206:
angle at which the device is placed on the skin and the force used to activate the device as well as how well the user follows the instructions for injection." It found that how well the user was trained was the most important factor determining successful delivery, and requested companies to develop better training materials for doctors and people to whom the devices are prescribed.
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failed to address known malfunctions in its auto-injectors even as hundreds of customer complaints rolled in and failures were linked to deaths. During an inspection, Meridian employees told inspectors that they weren't allowed to disassemble and investigate complain samples, because they were allowed to do if only it was “approved by management”.
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testified to Congress that Pfizer/King charged Mylan about $ 34.50 for one EpiPen. The devices deliver about $ 1 worth of drug. In September 2016, a Silicon Valley engineering consultancy performed a teardown analysis of the EpiPen and estimated the manufacturing and packaging costs at about $ 10 for
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The EpiPen, manufactured by Meridian Medical Technologies, and marketed by Mylan, has dominated the market. In 2007 when Mylan acquired the rights to market the product, annual sales of all epinephrine autoinjectors were about $ 200 million and EpiPen had around 90% of the market; in 2015 the market
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As of 2015, the following epinephrine autoinjectors were available in various parts of Europe: Adrenalina WZF, Adrenaline (epinephrine) 1 in 1000 solution for injection BP auto-injector, Altellus, Anapen, Emerade, EpiPen, Fastjekt, FastPen, and Jext. As of 2018, three branded products were available
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launched a policy initiative designed to "help state boards of education as they develop student health policies regarding anaphylaxis and epinephrine auto-injector access and use", and advocated for state laws protecting school from legal liability for stocking and using epinephrine autoinjectors.
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conducted a review of the safety of devices then on the market and found several factors that determine whether the devices successfully deliver drug into muscle, including "needle length, the thickness of fat under the skin, the way the auto-injector works (e.g., if it is spring loaded or not), the
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People to whom epinephrine autoinjectors are prescribed need to be trained how to use the specific device prescribed. The rate of unintentional injections using these devices is unknown but a 2009 review found that the rate is increasing. Unintentional injections are delivered to a finger or thumb
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The epinephrine in autoinjectors expires after one year. A study in rabbits showed that intramuscular epinephrine has decreased effectiveness after it expires; that study also recommended that if the drug in an expired device has not started to precipitate (if the solution is not cloudy and has no
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In response to criticism, Mylan increased financial assistance available for some patients to purchase EpiPens, a gesture that was called a "classic public relations move" by Harvard Medical School professor Aaron Kesselheim. The up to $ 300 saving cards can be used only by a small number of people
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On 5 September 2017, FDA posted a warning letter to the manufacturer, Meridian Medical Technologies. The agency warned Meridian Medical for failing to investigate problems with the devices, recall bad batches, and follow-up on problems found. According to the FDA, the manufacturer of EpiPen devices
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for the product, then known as "e-cue"; Pfizer, Mylan and Sanofi settled in 2012 under a deal that allowed the device to enter the market no earlier than November 2012, pending FDA approval. In August 2012, the FDA approved the autoinjector, called "Auvi-Q" after the FDA required a name change from
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and coauthors published a technique for obtaining multiple additional doses of epinephrine from used, single dose autoinjectors EpiPen and Adrenaclick. It was emphasized this was an emergency adaptation of the intended design for austere environments when no additional epinephrine was available. In
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After successful lobbying from Mylan, in 2013, the "School Access to Emergency Epinephrine Act" became law after passing Congress with broad and bipartisan support; it protected anyone from liability if they administered epinephrine to a child in a school (previously, only trained professionals or
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In 2003, Hollister-Stier received approval from the FDA to market an epinephrine autoinjector called Twinject that could deliver two shots of epinephrine, which it had spent ten years developing. In 2005, it sold the product to Verus Pharmaceuticals, which launched the product the same year. In
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In 2015 Mylan had about $ 1.5 billion in sales of EpiPens, which accounted for 40% of Mylan's profit. Mylan had maintained about a 90% market share since it had acquired the product, and had continually raised the price of EpiPens starting in 2009: in 2009, the wholesale price of two EpiPens was
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In October 2015, Auvi-Q and Allerject devices were voluntarily recalled by Sanofi in North America. The reason stated by Sanofi was that the products had been found to potentially have inaccurate dosage delivery, which may include failure to deliver drug. In February 2016, Sanofi terminated its
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to market a generic EpiPen in collaboration with Antares Pharma Inc, a maker of injection systems; Pfizer and King sued them for infringing US Patent 7,449,012 that was due to expire in 2025; Pfizer, Mylan, and Teva settled in April 2012 in a deal that allowed Teva to start selling the device in
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In 2009, Mylan and King started marketing a new version of EpiPen with the same basic mechanism but a stronger spring, better safety features, and clearer markings and instructions; an expert for NBC News estimated that the cost to redesign the device and packaging may have been "several million
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One of the people who helped in making the EpiPen was Richard B. Toren. He had the idea to use this technology for allergic reactions because his daughter was allergic to bees and had to carry around a complex kit if she was ever stung. He then helped to slightly alter the technology in order to
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on someone else's drug approval data - this pathway is used for example to get approval for an existing drug for a new indication. The information about the drug itself is someone else's, but the applicant has to generate the data showing the drug works for the new indication. In the case of
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called the Four Thieves Vinegar published a video and documents describing what they call an EpiPencil, an autoinjector which can be built using off-the-shelf parts, for a claimed price tag of about $ 30. At its core is a repurposed insulin autoinjector. This device has not been subject to any
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division of Pfizer, to begin selling an authorized generic of Adrenaclick. The media noted that Pfizer, through Greenstone, was marketing a generic epinephrine autoinjector when Pfizer acquired King later that year. At that time, King and Mylan's EpiPen had 91% of the global market share for
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the affected person were allowed to administer the drug, and were open to liability), and it provided some financial incentives for schools that didn't already stock epinephrine autoinjector to start stocking them. Joe Manchin, the father of Mylan's CEO, was a senator at that time.
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In June 2013, Amedra relaunched Adrenaclick. and at the same time, Lineage Therapeutics launched its authorized generic version of Adrenaclick. Lineage was a wholly owned subsidiary of Amedra that had acquired the rights to the Adrenaclick authorized generic from Greenstone/Pfizer.
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size was around $ 1.5 billion and Mylan still had about 90% of the market. Mylan raised the price from around $ 100 for a package of two EpiPens in 2007 to around $ 600 in 2016. In the United Kingdom, an EpiPen costs ÂŁ26.45 as of 2015. In Canada they are about 120 CAD each.
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around 90% of the time; they cause intense pain locally but usually completely resolve. The cause of unintentional injections has been attributed to design flaws, where the device is mistaken for a pen or the user mistakes which end of the device contains the needle.
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acquired the parent company of Amedra and Lineage, and placed Amedra and the Adrenaclick in its Impax Specialty Pharma division; at the same time it acquired Lineage, which it placed, along with its generic version of Adrenaclick, in its Impax Generics division.
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is for facial tissue; the company also successfully lobbied the FDA to broaden the label to include risk of anaphylaxis and in parallel, successfully lobbied Congress to generate legislation making EpiPens available in public places like
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solution. 5. Outer body. When retracted upward (left) exposes the needle and triggers the latch mechanism. Later springs back to cover the needle after use. 6. Needle exits through a protective barrier when this is pressed against the
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As of September 2016, two Jext autoinjectors cost users about ÂŁ8.50 (US$ 11.64) in Britain, and the National Health Service pays around ÂŁ48 (US$ 65.75) in order to make them available; that price was about 17 percent less than 2013.
2703: 2699:: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the Member States. Published April 25, 2014; Updated August 26, 2015. See 451:, had become president of the association in 2010, and shortly after had discussed donations from her "daughter's company" to the association. Manchin had been appointed to the West Virginia state school board by her husband 599:
Supplies of 150 microgram adrenaline auto-injectors were said to be “critical” in the United Kingdom in October 2018. Community pharmacists were told to prioritise supplies for children weighing 25 kg or less.
420:' Sandoz generic unit for patent infringement after Sandoz submitted an ANDA to sell a generic EpiPen. In response, Sandoz challenged the validity of the patents, and as of July 2016 this litigation was ongoing. 1023: 3348: 2193: 2141:"FDA-2015-P-0181: Requests that the FDA take certain actions with respect to abbreviated new drug application (ANDA) 90-589, submitted by Teva Pharmaceuticals (Teva), for an epinephrine auto-injector" 177:
The inner mechanism of an epinephrine autoinjector. 1. Four latch mechanisms that hold the plunger secure. 2. Loaded spring that drives the plunger and the needle (toward the right). 3. Plunger. 4.
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In 2001 Meridian and Dey introduced a two-pack version of the EpiPen; at that time the device had $ 23.9 million in annual sales and accounted for 75% of the market in the United States. In 2002
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but is not marketed. From 2015 to 2020 the only autoinjector marketed in Canada was EpiPen and production issues led to supply shortages during that period. During a 2018 shortage of EpiPens,
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acquired Meridian for $ 247.8 million in cash; the deal was completed in January 2003. Kaplan continued to improve his designs over the years, filing for example US Patent 6,767,336 in 2003.
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Muraro, A; The EAACI Food Allergy and Anaphylaxis Guidelines Group; et al. (August 2014). "Anaphylaxis: guidelines from the European Academy of Allergy and Clinical Immunology".
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In May 2015, the Emerade epinephrine autoinjector developed by the Swedish company Medeca was approved in Sweden and Germany; it had been approved in the UK in 2013. Also in 2015
672:. They do nothing about the high price which is still being paid by insurers, who ultimately pass the cost on to consumers. In October 2016, Mylan announced a settlement with the 632:, Mylan's CEO, saw an opportunity to increase sales in the US through marketing and advocacy, and the company launched a marketing campaign to increase awareness of the dangers of 458:
In 2012, Shionogi, the manufacturer of Adrenaclick and Twinject, announced it would stop making them; it had sold the rights to the NDA to a company called Amedra Pharmaceuticals.
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to sell EpiPens in bulk and with discounts to schools; to participate in the program schools had to agree not to buy epinephrine autoinjectors from any other company for a year.
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with the FDA raising concerns about TEVA's ANDA application to market a generic EpiPen and filed an additional supplement later in May; the FDA rejected the petition in June.
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announced on 9 July 2019 the availability of Symjepi, a manual epinephrine injection as an alternative to autoinjectors, in 0.3 mg and 0.15 mg versions.
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Simons, FE; Lieberman, PL; Read EJ, Jr; Edwards, ES (April 2009). "Hazards of unintentional injection of epinephrine from autoinjectors: a systematic review".
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The EpiPen had 89% of the market for epinephrine autoinjectors in 2015; in the first half of the year it had about 85% share and Auvi-Q had about 10% share.
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In an effort to address the supply shortage of EpiPens, on August 21, 2018 the FDA approved extending the expiration dates on some products by four months.
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Intelliject, it is the generic drug in a new device. For an explanation see Kenneth V. Phelps for Drug Discovery & Development Magazine. Aug 9, 2012
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and subpoenaed the company when it refused to provide the documentation the state requested. In October 2016, Mylan announced a $ 465M settlement with the
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In 2010, Sciele/Shionogi faced a recall of Twinject devices and launched Adrenaclick, a modified version of the Twinject that could deliver only one dose.
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involves misclassifying proprietary drugs as generic under the program. Under the agreement, Mylan agreed to pay a $ 465 million payment and to a sign a
3119: 279:, acquired the exclusive right to market and distribute the EpiPen. In 1998 there was a recall of one million EpiPens, the second such recall in a year. 2025: 1768: 2544: 1253: 3138: 2852: 2345: 1462: 1638:
Press Release: Shionogi Announces Positive Outcome to the Decentralized Procedure For The European Approval Of Twinject (Epinephrine Auto-Injector)
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As of 2020, three brands of autoinjectors are available in Canada: Allerject, Emerade, and EpiPen. One generic autoinjector has been approved by
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license to manufacture and market the Auvi-Q, leaving Kaléo (Intelliject was renamed) to consider how and whether to re-introduce the device.
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As of September 2016, two EpiPens cost around $ 100 in France and at maximum 10€ for members of the statutory health insurance in Germany.
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and the West Virginia State Attorney General opened an investigation into whether Mylan had given the state the correct discount under the
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as part of a larger transaction. At that time annual sales were around $ 200 million and the EpiPen had about 90% of the market.
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requiring it to perform better in the future; the settlement also resolved cases brought by states related to the rebates.
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Marketing Category: NDA Authorized Generic; Application Number Or Monograph: NDA020800; Marketing Start Date: 03/31/2010
677: 519: 511: 1855: 4171: 3098:"Mylan to provide EpiPen cost assistance as CEO is asked to testify on price hike | Business | The Guardian" 2407: 2275: 2235:"Emerade, 500 micrograms, solution for injection in pre-filled pen - Summary of Product Characteristics (SPC) - (eMC)" 2103: 1908: 1478: 1573:"Pfizer Completes Acquisition Of King Pharmaceuticals, Inc.; Pfizer and King begin joint operations on March 1, 2011" 1296: 1843: 1349: 4199: 3768: 1637: 2363: 2308:"Updated: Sanofi US Issues Voluntary Nationwide Recall of All Auvi-Q® Due to Potential Inaccurate Dosage Delivery" 498:
In March 2016, Teva's ANDA for a generic EpiPen, which had already faced several delays, was rejected by the FDA.
4247: 4176: 3763: 3710: 3544: 2520: 1597: 256:. The first modern epinephrine autoinjector, the EpiPen, was invented in the mid-1970s at Survival Technology in 202: 4166: 3540: 1920: 673: 515: 131: 95: 31: 3195: 271:
In 1996, Survival Technology merged with a company called Brunswick Biomedical and the new company was called
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administration because the latter may have delayed absorption. Minor adverse effects from epinephrine include
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March 2008, Sciele Pharma acquired Twinject from Verus and later that year, Sciele was acquired by Shionogi.
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The devices contain a fixed dose of epinephrine and a spring-loaded needle (or, in the case of AuviQ, a CO
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In 2010, European regulators approved Twinject, and also approved a new epinephrine autoinjector made by
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dollars" and the cost to retool the manufacturing process may have "run into the double-digit millions."
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In 2009, Intelliject, a US startup developing a new epinephrine autoinjector, licensed their product to
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particles in it) using the expired device is better than no injection at all in an emergency situation.
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Press Release: Sciele Pharma Acquires Twinject® Epinephrine Auto-Injector from Verus Pharmaceuticals
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Press Release: Impax Completes Acquisition Of Tower Holdings, Inc. And Lineage Therapeutics Inc.
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Simons, KJ; Simons, FE (August 2010). "Epinephrine and its use in anaphylaxis: current issues".
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Epinephrine autoinjectors are hand-held devices carried by those who have severe allergies; the
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and sold under the brand name Jext. Jext was launched in the European Union in September 2011.
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When anaphylaxis is suspected, epinephrine solution should be given as soon as possible as an
2104:"How Congress, the FDA, and Sarah Jessica Parker Helped EpiPen Become a $ 1 Billion Business" 232:
2016, Robinson and Lareau published a similar technique adapted to used AuviQ autoinjectors.
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Mylan acquired the right to market the EpiPen line of epinephrine autoinjector devices from
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In 2011, Pfizer and King sued Intelliject and Sanofi after the companies filed a 505(b)(2)
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QUIC FORM 201313 Adrenaclick Auto-Injector, NDC 59630-0803-02 And 59630-0804-02 Resolution
1951: 1601: 1170: 760:"Anaphylaxis in children: current understanding and key issues in diagnosis and treatment" 567:
As of 2005, epinephrine autoinjectors were not available in most of the developing world.
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Note - a "505(b)(2)" is a kind of new drug application that allows the applicant to rely
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Press Release: Lineage Therapeutics Markets Authorized Generic Epinephrine Auto-Injector
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Press Release: Mylan and Pfizer Announce Epinephrine Auto-injector Settlement Agreement
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On 16 August 2018 the FDA approved the first generic EpiPen from Teva Pharmaceuticals.
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temporarily permitted the importation of Auvi-Q autoinjectors from the United States.
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Tara Parker-Pope and Rachel Rabkin Peachman for the New York Times. Aug 22, 2016
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Cynthia Koons and Robert Langreth for Bloomberg Businessweek. September 23, 2015
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As of May 2019, in Canada the wholesale cost of a single EpiPen is approximately
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Registration Statement under The Securities Act Of 1933. Filed April 30, 1999
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Press Release: King Pharmaceuticals to Acquire Meridian Medical Technologies
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Hawkins, SC; Weil, C; Baty, F; Fitzpatrick, D; Rowell, B (September 2013).
1005: 957: 903: 860: 793: 2828:"EpiPen shortage: What are your alternative epinephrine injector options?" 2569:"Teva Pharmaceutical Gains Approval for Generic EpiPen, Mylan Shares Flat" 46: 4263: 4252: 4044: 4024: 4019: 3993: 3937: 3830: 3820: 3815: 3572: 3518: 3483: 3468: 3410: 2659:"Adamis Pharmaceuticals Provides Update on U.S. Retail Launch of SYMJEPI" 1375:"Verus Pharmaceuticals Announces U.S. Launch of Twinject for Anaphylaxis" 1092:"Novel Technique for Epinephrine Removal in New Generation Autoinjectors" 932:"Anaphylaxis treatment: current barriers to adrenaline auto-injector use" 669: 536: 417: 3218: 1884: 1856:
Quarterly Report (Form 10-Q) for the quarterly period ended July 3, 2016
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Press Release: Amedra Pharmaceuticals Markets Adrenaclick Auto-Injector
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John Reid Blackwell for the Richmond Times-Dispatch. August 14, 2012
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program in New York to determine if the program's contracts violated
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ALK Pharma Jext300, adrenaline autoinjector, without its safety cover
3139:"Is EpiPen a Brand-Name or a Generic Drug? Mylan Casts It Both Ways" 3042:"Drug company stung by criticism of 'outrageous' EpiPen price rises" 2594:"Press Announcements - FDA approves first generic version of EpiPen" 2521:"2017 - Meridian Medical Technologies, Inc. a Pfizer Company 9/5/17" 2346:"Sanofi abandoning Auvi-Q after dosage problems led to total recall" 660:'s competing product was recalled in November 2015 and further when 604:
identified shortages because of manufacturing problems in May 2018.
106:. The first epinephrine autoinjector was brought to market in 1983. 3675: 2296:. Canadian Broadcasting Company. Associated Press. 30 October 2015. 2294:"Allerject epinephrine auto-injectors recalled by drugmaker Sanofi" 1909:
FDA approves Intelliject's life-saving device for allergy sufferers
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FDA swats down Teva's EpiPen copy, putting Mylan in cruise control
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Mylan's efforts to maintain its market dominance were aided when
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Jennifer Sudick for the Spokane Spokesman-Review. July 20, 2005
94:) is a medical device for injecting a measured dose or doses of 3330: 2479:"Mylan Investigations Mount as West Virginia Opens Fraud Probe" 2408:"People With Food Allergies Say Life-Saving Drug Too Expensive" 2261:"Valeant Form 10-K For the fiscal year ended December 31, 2015" 1417:
Z+Kazuhiro Shimamua for The Wall Street Journal. Sept. 1, 2008
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How Marketing Turned the EpiPen Into a Billion-Dollar Business
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This article is about the autoinjector. For medical uses, see
2959:(69 ed.). Joint Formulary Committee. 2015. p. 215. 2435:
Walker, Joseph; Winslow, Ron; Steele, Anne (30 August 2016).
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deal primarily with the United States and do not represent a
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Press Release: Meridian Announces Launch Of New EpiPen 2-Pak
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Meridian Medical Technologies, Merck KGaA. April 03, 2001
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were originally developed for the rapid administration of
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National Council for Prescription Drug Programs May 2013
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and was first approved for marketing by the FDA in 1987.
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Mylan, Pfizer Reach Epinephrine-Pen Settlement With Teva
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Press Release: Sanofi Announces FDA Approval for Auvi-Q
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Staff, Monthly Prescribing Reference. January 07, 2010
1133:"EpiPen inventor helped millions and died in obscurity" 653:
had worked with on defibrillator legislation to do so.
553:
in the United States: Adrenaclick, Auvi-Q, and EpiPen.
337: 102:
technology. It is most often used for the treatment of
2701:
Index page for EMA Review of Adrenaline auto-injectors
2123:"Could EpiPen's plastic cap be Mylan's secret weapon?" 1477:
Johnson, Carolyn Y.; Ho, Catherine (August 25, 2016).
1438:
EpiPen Price Rise Sparks Concern for Allergy Sufferers
1362:
Approval History NDA 020800 - Twinject and Adrenaclick
640:
brand as identified with epinephrine autoinjectors as
134:
delivered by the device is an emergency treatment for
3196:"Hackers Offer a DIY Alternative to the $ 600 EpiPen" 2454:
Larson, Erik; Hopkins, Jared S. (September 6, 2016).
728:
National Institute of Allergy and Infectious Diseases
2879:"Allergien: Diese Kosten ĂĽbernimmt die Krankenkasse" 2437:"Mylan to Launch Cheaper Generic EpiPen Alternative" 2237:. UK Electronic Medicines Compendium. Archived from 413:
epinephrine autoinjectors and 96% of the US market.
4213: 4185: 4157: 4110: 4077: 3958: 3896: 3849: 3785: 3735: 3691: 3651: 3637: 3602: 3553: 3531: 3444: 3391: 3377: 3368: 3181:, Adam Rubenfire, Modern Healthcare, March 28, 2016 2826:Hyshka, Ashley; McLaughlin, Ross (28 August 2019). 2477:Feeley, Jef; Langreth, Robert (20 September 2016). 1561:
Brothers Develop New Device to Halt Allergy Attacks
56: 39: 1769:"Generic Epinephrine Injector May Cause Confusion" 1614:Adrenaclick Auto-injector launched for anaphylaxis 1299:filed For the fiscal year ended December 31, 2003. 884:Current Opinion in Allergy and Clinical Immunology 408:Also in 2010, Shionogi authorized Greenstone, the 51:Mylan 0.3 mg EpiPen, epinephrine autoinjector 3012: 3010: 1987: 1985: 1714:Paton, James; Kresge, Naomi (29 September 2016). 1559:Katie Thomas for the New York Times. Feb 1, 2013 1555: 1553: 1457: 1455: 1453: 1451: 1449: 1447: 1445: 1248: 1246: 440:National Association of State Boards of Education 118:Vastus lateralis site for intramuscular injection 3179:Lack of competition leads to EpiPen pricing woes 1970:Swetlitz, Ike; Silverman, Ed (August 26, 2016). 1810:: CS1 maint: bot: original URL status unknown ( 1795:"EPINEPHRINE injection [Greenstone LLC]" 1709: 1707: 1705: 1496: 1494: 1492: 1391:: CS1 maint: bot: original URL status unknown ( 925: 923: 921: 753: 751: 749: 2749:"Epinephrine autoinjectors available in Canada" 2496: 2494: 2492: 1544:Phil Milford for Bloomberg News April 26, 2012 930:Song, TT; Worm, M; Lieberman, P (August 2014). 676:over rebates paid by Mylan to states under the 636:for people with severe allergies that made the 518:over rebates paid by Mylan to states under the 1750:"Pfizer to Make Generic Version of Its Zoloft" 1735:"Greenstone LLC - A Successful Business Model" 1579:(press release). March 1, 2011. Archived from 3342: 2647:. United States Food and Drug Administration. 2430: 2428: 2084:. Magellan Medical. July 2013. Archived from 1965: 1963: 1961: 1959: 979: 977: 975: 326:The examples and perspective in this section 297:acquired the right to market the EpiPen from 8: 3189: 3187: 2375: 2373: 2371: 1823: 1821: 1716:"Why the $ 600 EpiPen Costs $ 69 in Britain" 695:of Adrenaclick cost $ 142 at retail stores. 3001:Carly Helfand for FiercePharma Mar 1, 2016 2401: 2399: 1844:King Pharma Sues Sandoz Over Generic EpiPen 1483:The Washington Post via The Chicago Tribune 1472: 1470: 1381:. Archived from the original on 2005-12-22. 1022:European Medicines Agency (June 26, 2015). 834: 832: 830: 828: 826: 824: 4107: 3648: 3550: 3388: 3374: 3349: 3335: 3327: 1842:Julie Zeveloff for Law360. July 16, 2010. 1432: 1430: 1428: 1426: 1338:Spokane firm sells rights to auto-injector 986:Annals of Allergy, Asthma & Immunology 344:, or create a new section, as appropriate. 45: 3300: 3264: 1332: 1330: 1267:"EpiPen Recall PointsTo Broader Concerns" 1107: 1066: 1017: 1015: 947: 783: 718: 716: 431:In 2012, Mylan launched a program called 360:Learn how and when to remove this message 3113: 3111: 2743: 2741: 2364:Teva suffers setback over EpiPen generic 1183:Approval history for NDA 019430 - EpiPen 3061:"Have You Ever Tried to Buy an EpiPen?" 2885:(in German). 2019-01-24. Archived from 2641:"Extended Use Dates Provided by Pfizer" 2362:Staff, The Pharma Letter. 3 March 2016 1992:O'Donnell, Jayne (September 21, 2016). 1690:"ALK media release (06 September 2011)" 1227:For the fiscal year ended July 31, 1997 1096:Wilderness & Environmental Medicine 1055:Wilderness & Environmental Medicine 712: 455:, then-governor of the state, in 2012. 3194:Eliza Strickland (19 September 2016). 3118:Carolyn Y. Johnson (August 25, 2016). 3029:from the original on January 19, 2021. 2053:Amedra Pharmaceutical June 14th, 2013 1803: 1384: 36: 2276:"Auvi-Q auto injector being recalled" 2121:Gibney, Michael (September 1, 2016). 1670:"ALK media release (13 October 2010)" 1650:"ALK media release (07 October 2010)" 1131:Smetana, Kevin (September 24, 2009). 1090:Robinson, P; Lareau, S (April 2016). 7: 2859:. The Canadian Press. August 9, 2018 2406:Goldberg, Kenny (18 February 2016). 2380:Bartolotta, Devin (18 August 2016). 2042:FY2011 Financial Results: Supplement 649:are, and hired the same people that 3706:Heated humidified high-flow therapy 3217:Laufer, Dr. Mixæl S. (2016-09-19). 2957:British National Formulary (BNF) 69 2065:Lineage Therapeutics. Jun 14, 2013 1252:King Pharmaceuticals Oct 21, 2002. 703:validation by regulatory agencies. 395:in 2010 for $ 3.6 billion in cash. 223:An injection of Auvi-Q autoinjector 65: 3137:Thomas, Katie (2 September 2016). 3081:Ginger Skinner (August 11, 2016). 2344:Stanton, Dan (February 26, 2016). 2325:Spiers, Jonathan (21 March 2016). 2143:. US Government Dockets Repository 1501:Popken, Ben (September 30, 2016). 764:Current Allergy and Asthma Reports 25: 2274:Tammie Smith (October 29, 2015). 668:who need the drug, and no one on 4148: 3674: 3435: 3429: 3302:10.1111/j.1398-9995.2010.02450.x 3253:The American Journal of Medicine 3096:Kasperkevic, Jana (2016-08-25). 3059:Khazan, Olga (August 24, 2016). 2501:Thomas, Katie (7 October 2016). 2044:See note in the margin of page 6 1162:National Inventors Hall of Fame 730:. April 23, 2015. Archived from 381:mid-2015, pending FDA approval. 317: 275:. In 1997, Dey, a subsidiary of 268:create EpiPen's current design. 3083:"Can You Get A Cheaper EpiPen?" 3040:Lamble, Kate (25 August 2016). 2774:Young, Leslie (2 August 2018). 2102:Novak, Matt (August 23, 2016). 1748:Hensley, Scott (29 June 2006). 1626:Adrenaclick original label 2009 1405:Sciele Pharma. March 13, 2008. 2613:Novak, Matt (22 August 2018). 1883:Sherri Oslick for PatentDocs. 1265:Chase, Marilyn (18 May 1998). 1223:Meridian Medical Technologies 698:In September 2016, a group of 469:In January 2015 Mylan filed a 416:In 2010, Pfizer and King sued 1: 3474:Effervescent powder or tablet 3156:Mole, Beth (7 October 2016). 3017:Tuttle, Brad (Aug 22, 2016). 1885:Court Report January 23, 2011 1828:Edwards, Jim (Oct 12, 2010). 1419:Shionogi to Buy Sciele Pharma 1364:Page accessed August 25, 2016 998:10.1016/s1081-1206(10)60332-8 686:corporate integrity agreement 273:Meridian Medical Technologies 227:In 2013, emergency physician 4258:Patient-controlled analgesia 3563:Orally disintegrating tablet 3266:10.1016/j.amjmed.2016.07.018 3247:Fromer, L (20 August 2016). 2599:Food and Drug Administration 896:10.1097/ACI.0b013e32833bc670 758:Dinakar, C (December 2012). 678:Medicaid Drug Rebate Program 628:as part of their 2007 deal. 520:Medicaid Drug Rebate Program 512:Medicaid Drug Rebate Program 4324:Social problems in medicine 3219:"Introducing the EpiPencil" 1238:Amendment No. 3 to Form S-1 612:In October 2016 the CEO of 340:, discuss the issue on the 252:antidotes in kits like the 4345: 3769:Relative analgesia machine 2163:"Impax 2014 Annual Report" 1873:Taking the 505(b)(2) Route 1636:Shionogi. August 31, 2010 1185:Page accessed Aug 30, 2016 157:, anxiety, headaches, and 29: 4304:Drugs developed by Pfizer 4146: 3672: 3427: 3283:Frew, AJ (January 2011). 1350:Twinject Approval Package 1109:10.1016/j.wem.2016.02.005 1068:10.1016/j.wem.2013.03.025 776:10.1007/s11882-012-0284-1 447:, mother of Mylan's CEO, 203:European Medicines Agency 98:(adrenaline) by means of 66: 44: 4309:Drugs developed by Merck 3358:Routes of administration 1733:Staff (August 1, 2008). 1200:www.adeliberatepause.com 674:US Department of Justice 516:US Department of Justice 81:epinephrine autoinjector 40:Epinephrine autoinjector 32:Epinephrine (medication) 4299:Type I hypersensitivity 3884:Extra-amniotic infusion 3489:Molecular encapsulation 3421:Osmotic delivery system 3416:Time release technology 2280:Richmond Times-Dispatch 1943:Sanofi August 13, 2012 818:Last revised 03/15/2017 808:"Epinephrine Injection" 691:As of August 2016, the 535:The Sandoz division of 192:intramuscular injection 147:vastus lateralis muscle 143:intramuscular injection 85:adrenaline autoinjector 4187:Central nervous system 3975: 3913: 3841:Mucoadhesive microdisc 3806: 3225:. Four Thieves Vinegar 3223:fourthievesvinegar.org 2350:in-Pharma Technologist 438:In December 2012, the 224: 183: 127: 119: 4314:Pricing controversies 4294:Drug delivery devices 4030:Transfersome vesicles 3974: 3912: 3889:Intravesical infusion 3805: 2883:Biallo Versicherungen 2621:. Gizmodo Media Group 2192:Impax March 10, 2015 2091:on September 9, 2016. 1295:King Pharmaceuticals 1030:on September 10, 2016 445:Gayle Conelly Manchin 391:King was acquired by 222: 176: 125: 117: 3716:Metered-dose inhaler 3701:Anesthetic vaporizer 1895:Mylan. Feb 16, 2012 1521:"Automatic injector" 1310:"Automatic injector" 1138:St. Petersburg Times 682:pharmaceutical fraud 425:New Drug Application 374:Teva Pharmaceuticals 338:improve this section 284:King Pharmaceuticals 241:Product introduction 87:, also known by the 4141:Transdermal implant 4101:(into tissue/blood) 3878:Intrauterine device 3759:Anaesthetic machine 3754:Oxygen concentrator 3085:. Consumer Reports. 2753:Therapeutics Letter 2724:Food Allergy Canada 2602:. 20 February 2020. 2441:Wall Street Journal 1921:"Auvi-Q Fact Sheet" 1754:Wall Street Journal 1271:Wall Street Journal 1145:on February 1, 2013 543:Society and culture 410:authorized generics 4253:Nanocell injection 3976: 3914: 3807: 3661:Dry-powder inhaler 3143:The New York Times 2937:. The Mercury News 2914:on 3 December 2018 2857:The Globe and Mail 2706:2018-07-10 at the 2695:2018-06-18 at the 2507:The New York Times 2199:2016-08-27 at the 2028:2017-08-02 at the 2017:2016-09-14 at the 1950:2017-01-31 at the 1775:on August 29, 2016 1600:2016-08-29 at the 1525:Patents.google.com 1314:Patents.google.com 1169:2016-01-31 at the 693:authorized generic 478:Impax Laboratories 309:Market development 260:, Maryland, US by 225: 184: 128: 120: 4276: 4275: 4272: 4271: 4103: 4065:Transdermal spray 4060:Transdermal patch 4050:Medicated shampoo 3781: 3780: 3777: 3776: 3764:Medical inhalants 3711:Medical inhalants 3639:Respiratory tract 3633: 3632: 3527: 3526: 3259:(12): 1244–1250. 2726:. 20 October 2020 2412:KPBS Public Media 2331:Richmond BizSense 2241:on 3 October 2016 1832:. CBS MoneyWatch. 1737:. Pharmacy Times. 1583:on June 30, 2013. 949:10.1111/all.12387 853:10.1111/all.12437 370: 369: 362: 220: 77: 76: 16:(Redirected from 4336: 4152: 4108: 4099: 3686: 3682: 3678: 3649: 3578:Sublingual drops 3551: 3439: 3433: 3389: 3375: 3351: 3344: 3337: 3328: 3322: 3304: 3278: 3268: 3234: 3233: 3231: 3230: 3214: 3208: 3207: 3205: 3203: 3191: 3182: 3176: 3170: 3169: 3167: 3165: 3153: 3147: 3146: 3134: 3128: 3127: 3115: 3106: 3105: 3093: 3087: 3086: 3078: 3069: 3068: 3056: 3050: 3049: 3037: 3031: 3030: 3014: 3005: 2999: 2993: 2992: 2990: 2988: 2977: 2971: 2970: 2953: 2947: 2946: 2944: 2942: 2930: 2924: 2923: 2921: 2919: 2904: 2898: 2897: 2895: 2894: 2875: 2869: 2868: 2866: 2864: 2849: 2843: 2842: 2840: 2838: 2823: 2817: 2816: 2814: 2812: 2807:. April 12, 2018 2797: 2791: 2790: 2788: 2786: 2771: 2765: 2764: 2745: 2736: 2735: 2733: 2731: 2716: 2710: 2686: 2680: 2679: 2677: 2676: 2655: 2649: 2648: 2637: 2631: 2630: 2628: 2626: 2610: 2604: 2603: 2590: 2584: 2583: 2581: 2580: 2571:. 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Archived from 1192: 1186: 1179: 1173: 1160: 1154: 1153: 1151: 1150: 1141:. Archived from 1128: 1122: 1121: 1111: 1087: 1081: 1080: 1070: 1046: 1040: 1039: 1037: 1035: 1026:. Archived from 1019: 1010: 1009: 981: 970: 969: 951: 927: 916: 915: 879: 873: 872: 836: 819: 817: 804: 798: 797: 787: 755: 744: 743: 741: 739: 720: 583: 471:citizen petition 365: 358: 354: 351: 345: 321: 320: 313: 221: 70:edit on Wikidata 49: 37: 21: 4344: 4343: 4339: 4338: 4337: 4335: 4334: 4333: 4279: 4278: 4277: 4268: 4248:Intraperitoneal 4220:musculoskeletal 4218: 4209: 4181: 4177:Intra-articular 4153: 4144: 4104: 4098: 4097: 4073: 3954: 3892: 3845: 3790: 3773: 3731: 3687: 3684: 3683: 3680: 3679: 3670: 3629: 3598: 3523: 3440: 3434: 3425: 3379:Digestive tract 3364: 3355: 3282: 3246: 3243: 3241:Further reading 3238: 3237: 3228: 3226: 3216: 3215: 3211: 3201: 3199: 3198:. IEEE Spectrum 3193: 3192: 3185: 3177: 3173: 3163: 3161: 3155: 3154: 3150: 3136: 3135: 3131: 3124:Washington Post 3117: 3116: 3109: 3095: 3094: 3090: 3080: 3079: 3072: 3058: 3057: 3053: 3039: 3038: 3034: 3016: 3015: 3008: 3000: 2996: 2986: 2984: 2979: 2978: 2974: 2967: 2955: 2954: 2950: 2940: 2938: 2933:Tracy, Seipel. 2932: 2931: 2927: 2917: 2915: 2906: 2905: 2901: 2892: 2890: 2877: 2876: 2872: 2862: 2860: 2851: 2850: 2846: 2836: 2834: 2825: 2824: 2820: 2810: 2808: 2799: 2798: 2794: 2784: 2782: 2773: 2772: 2768: 2747: 2746: 2739: 2729: 2727: 2718: 2717: 2713: 2708:Wayback Machine 2697:Wayback Machine 2687: 2683: 2674: 2672: 2657: 2656: 2652: 2639: 2638: 2634: 2624: 2622: 2612: 2611: 2607: 2592: 2591: 2587: 2578: 2576: 2567: 2566: 2562: 2553: 2551: 2543: 2542: 2538: 2529: 2527: 2519: 2518: 2514: 2500: 2499: 2490: 2476: 2475: 2471: 2461: 2459: 2453: 2452: 2448: 2434: 2433: 2426: 2416: 2414: 2405: 2404: 2397: 2387: 2385: 2384:. CBS Baltimore 2379: 2378: 2369: 2361: 2357: 2343: 2342: 2338: 2324: 2323: 2319: 2306: 2305: 2301: 2292: 2291: 2287: 2273: 2272: 2268: 2259: 2258: 2254: 2244: 2242: 2233: 2232: 2228: 2218: 2216: 2211: 2210: 2206: 2201:Wayback Machine 2191: 2187: 2178: 2176: 2172: 2165: 2161: 2160: 2156: 2146: 2144: 2139: 2138: 2134: 2120: 2119: 2115: 2101: 2100: 2096: 2088: 2081: 2077: 2076: 2072: 2064: 2060: 2052: 2048: 2039: 2035: 2030:Wayback Machine 2019:Wayback Machine 2009: 2005: 1991: 1990: 1983: 1969: 1968: 1957: 1952:Wayback Machine 1942: 1938: 1928: 1926: 1923: 1919: 1918: 1914: 1906: 1902: 1894: 1890: 1882: 1878: 1865: 1861: 1853: 1849: 1841: 1837: 1827: 1826: 1819: 1802: 1793: 1792: 1788: 1778: 1776: 1767:Tucker, Janna. 1766: 1765: 1761: 1747: 1746: 1742: 1732: 1731: 1727: 1713: 1712: 1703: 1694: 1692: 1688: 1687: 1683: 1674: 1672: 1668: 1667: 1663: 1654: 1652: 1648: 1647: 1643: 1635: 1631: 1623: 1619: 1611: 1607: 1602:Wayback Machine 1592: 1588: 1571: 1570: 1566: 1558: 1551: 1543: 1539: 1529: 1527: 1519: 1518: 1514: 1500: 1499: 1490: 1476: 1475: 1468: 1460: 1443: 1435: 1424: 1416: 1412: 1404: 1400: 1383: 1373: 1372: 1368: 1359: 1355: 1347: 1343: 1335: 1328: 1318: 1316: 1308: 1307: 1303: 1294: 1290: 1282: 1278: 1264: 1263: 1259: 1251: 1244: 1235: 1231: 1222: 1218: 1209: 1207: 1194: 1193: 1189: 1180: 1176: 1171:Wayback Machine 1161: 1157: 1148: 1146: 1130: 1129: 1125: 1089: 1088: 1084: 1048: 1047: 1043: 1033: 1031: 1021: 1020: 1013: 983: 982: 973: 929: 928: 919: 881: 880: 876: 838: 837: 822: 806: 805: 801: 757: 756: 747: 737: 735: 722: 721: 714: 709: 610: 590: 581: 578: 573: 550: 545: 476:In March 2015, 366: 355: 349: 346: 335: 322: 318: 311: 243: 238: 229:Seth C. Hawkins 209: 189: 171: 112: 73: 52: 35: 28: 23: 22: 15: 12: 11: 5: 4342: 4340: 4332: 4331: 4326: 4321: 4316: 4311: 4306: 4301: 4296: 4291: 4281: 4280: 4274: 4273: 4270: 4269: 4267: 4266: 4261: 4255: 4250: 4245: 4240: 4235: 4230: 4224: 4222: 4211: 4210: 4208: 4207: 4202: 4197: 4191: 4189: 4183: 4182: 4180: 4179: 4174: 4169: 4167:Intracavernous 4163: 4161: 4155: 4154: 4147: 4145: 4143: 4138: 4137: 4136: 4126: 4121: 4119: 4105: 4096: 4095: 4090: 4085: 4079: 4078: 4075: 4074: 4072: 4067: 4062: 4057: 4052: 4047: 4042: 4037: 4032: 4027: 4022: 4017: 4012: 4006: 4001: 3996: 3991: 3986: 3981: 3969: 3967: 3956: 3955: 3953: 3952: 3950:Nutrient enema 3947: 3942: 3941: 3940: 3935: 3925: 3920: 3907: 3905: 3894: 3893: 3891: 3886: 3881: 3875: 3870: 3865: 3860: 3855: 3853: 3847: 3846: 3844: 3843: 3838: 3833: 3828: 3823: 3818: 3813: 3800: 3798: 3783: 3782: 3779: 3778: 3775: 3774: 3772: 3771: 3766: 3761: 3756: 3751: 3741: 3739: 3733: 3732: 3730: 3729: 3724: 3719: 3713: 3708: 3703: 3697: 3695: 3689: 3688: 3673: 3671: 3669: 3668: 3663: 3657: 3655: 3646: 3635: 3634: 3631: 3630: 3628: 3627: 3624: 3619: 3614: 3608: 3606: 3600: 3599: 3597: 3596: 3591: 3585: 3580: 3575: 3570: 3565: 3559: 3557: 3548: 3529: 3528: 3525: 3524: 3522: 3521: 3516: 3511: 3506: 3501: 3496: 3491: 3486: 3481: 3476: 3471: 3466: 3461: 3456: 3450: 3448: 3442: 3441: 3428: 3426: 3424: 3423: 3418: 3413: 3408: 3403: 3397: 3395: 3386: 3372: 3366: 3365: 3356: 3354: 3353: 3346: 3339: 3331: 3325: 3324: 3280: 3242: 3239: 3236: 3235: 3209: 3183: 3171: 3160:. 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Index

Epipen
Epinephrine (medication)

edit on Wikidata
trademark
epinephrine
autoinjector
anaphylaxis


epinephrine
anaphylaxis
intramuscular injection
vastus lateralis muscle
subcutaneous
tremors
palpitations

Adrenaline
intramuscular injection
European Medicines Agency
Seth C. Hawkins
Autoinjectors
nerve gas
Mark I NAAK
Bethesda
Sheldon Kaplan
Meridian Medical Technologies
Merck KGaA
King Pharmaceuticals

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