Photo : Drew Angerer ( Getty Images ) A life-saving but increasingly expensive treatment for severe allergic attacks is poised to become cheaper. Advertisement On Thursday, the Food and Drug Administration announced its approval of a generic version of the EpiPen and EpiPen Jr sold by pharmaceutical company Mylan. The approval comes in the wake of several scandals involving Mylan’s version, including an ongoing shortage of the drug. The EpiPen is an auto-injectable device that shoots the hormone epinephrine into your system, rapidly halting the symptoms of a life-threatening allergic reaction. The hormone itself, perhaps better known as adrenaline, has long been generic and cheap to obtain. But the technology inside the EpiPen, developed in 1977, that allows it to be easily used by anyone with proper training is another story. Though there are other epinephrine autoinjectors available, Mylan has fiercely defended its stranglehold on the market, allowing it to keep raising prices. In 2007, when Mylan first bought its marketing rights, an EpiPen was $57, but by 2016, it had risen to around $600. Along the way, Mylan has reportedly bullied companies trying to develop cheaper versions of their product, including Teva Pharmaceuticals—the company behind the generic version approved by the FDA today. Teva had earlier failed to win approval for their version in 2016 and has sought to create a generic version since at least 2009. “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages,” said FDA Commissioner Scott Gottlieb in a statement. In May, the FDA officially placed the EpiPen on its shortages list, following numerous manufacturing delays at the sole St. Louis factory where the product is produced. (Mylan markets Epipen, but it has a manufacturing partnership with the pharmaceutical company Pfizer.) The company has also had to deal with a growing number of reports concerning defective EpiPens believed to have injured and even killed users, according to internal FDA documents obtained by Bloomberg News. Though the company has often brushed aside the swell of criticism over its high prices (sometimes by flat out lying about their profits), it’s also tried to worm itself back into the public’s good graces. In 2016, Mylan won approval to produce and sell their own generic version of the EpiPen. This version still sold for about $300, with the only difference being the lack of a brand name label. Last year, it also entered a $465 million settlement with the federal government over claims that it had ripped off Medicaid and Medicare (the company was allowed not to admit any wrongdoing). Ironically, it was accused of doing so by allegedly misrepresenting their product as a generic drug, apparently allowing them to overcharge for it. Advertisement If there’s one bright side to all this, it’s that Mylan’s tricks have seemingly started to fall flat: Its revenue from the EpiPen has steadily fallen in recent years. It’s unclear at this point how much Teva’s generic version will cost, though a generic version of a similar epinephrine autoinjector now costs around $100. Teva did not immediately respond to a request for comment from Gizmodo. Advertisement [FDA]<doc-sep>The EpiPen, made by Mylan, is used to inject the hormone epinephrine into the thigh to quell potentially fatal reactions to bee stings, peanuts and other allergens. Although the key ingredient is cheap and the EpiPen itself was first approved in 1987, Mylan began increasing the price of the product, from less than $100 in 2007 for a pack of two injectors to $608 today. In response to criticism over the price of its drug, EpiPen introduced its own half-priced generic in 2016.<doc-sep>Mylan’s life-saving epinephrine auto-injector EpiPen now has a generic rival, the Food and Drug Administration triumphantly announced. Teva Pharmaceuticals USA now has FDA approval to market a direct generic competitor of the device, as well as a version for pediatric patients, a generic EpiPen Jr. Both products are used in emergency situations to auto-inject a dose of epinephrine into a person’s thigh to thwart deadly allergic reactions, namely anaphylactic shock. The approval comes years after Mylan outraged patients and lawmakers by ruthlessly hiking the price of its product by more than 400 percent. Mylan purchased the rights to EpiPen in 2007 and gradually raised the list price from about $50 per auto-injector to slightly over $600 for a two-pack. The move boosted EpiPen profits to $1.1 billion a year. In step, Mylan CEO Heather Bresch saw her salary soar by millions, reaching nearly $19 million in 2015— a point lawmakers hammered her for during a House Oversight Committee hearing in September of 2016. Amid the intense scrutiny, Mylan announced that it would release its own “authorized generic” version of the EpiPen. But the product debuted with a list price of $300 per two-pack, still triple the price of what the product cost prior to Mylan’s 2007 takeover. Epinephrine alone is already a generic drug, and the dose in an auto-injector costs less than a dollar to make. But the EpiPen is a drug-device “combination product,” which has been tricky for rivals to replicate exactly in order to get FDA approval. Mylan has also been accused by fellow pharmaceutical companies of trying to squash rivals In 2009, Mylan had Teva sued for patent infringement, leading to a settlement that kept Teva off the EpiPen market until 2015. Then, in 2016, the FDA found “major deficiencies” in Teva’s application to market a rival EpiPen generic. Since then, other makers have made different types of epinephrine auto-injectors, most notably Adrenaclick and the pricy Auvi-Q, but they work differently from EpiPen and can’t be used interchangeably like a generic version. Advertisement Teva’s long-sought generic now offers patients that option—and the potential for lower prices. In a statement, FDA Commissioner Scott Gottlieb trumpeted the approval as a win in the effort to drag down skyrocketing drug costs: Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval. Still, Teva has yet to name the price of its generic, ensuring that the FDA’s hopes are indeed true. Two Teva spokespeople declined to reveal any hints on the device’s list price to Ars. They only provided a written statement:<doc-sep>Story highlights FDA approves the first generic version of EpiPen The approval comes on the heels of an EpiPen shortage and soaring drug costs (CNN) — The US Food and Drug Administration has approved the first generic competitor to EpiPen and EpiPen Jr. for the emergency treatment of allergic reactions in adults and children. The company Teva Pharmaceuticals gained approval to market the new generic drug, according to an announcement from the FDA on Thursday. Brendan O’Grady, executive vice president who heads North America Commercial at Teva, noted in an emailed statement Thursday that the approval “marks an important step forward in bringing our patients additional prescription medications that have met the FDA’s rigorous standards.” “We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market,” the statement said. No details are available regarding the cost of the new generic or precisely when it will be available. ’A lower-cost option’ The approval of the generic drug comes after EpiPens were added to the FDA’s drug shortage list in May and two years after the maker of EpiPen, pharmaceutical company Mylan, increased costs of its product by more than 400%, leading to public outrage. The newly approved generic offers an alternative for patients who, until now, have been able to use only the brand-name EpiPen. “Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” FDA Commissioner Dr. Scott Gottlieb said in the announcement. “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages,” he said. EpiPen is an auto-injector that delivers epinephrine, more commonly known as adrenaline, a hormone that can help relax muscles in the airways and tighten blood vessels. It can open the airways and reduce swelling during a severe allergic reaction. Epinephrine injection is used along with emergency medical treatment for life-threatening reactions caused by allergies to insect bites or stings, foods, medications, latex or other causes. Yet “the path to developing generic drug-device combination products like this one is challenging,” Gottlieb said, because combination drugs consist of two parts: the drug, such as epinephrine, and the device, such as the auto-injector. “We remain committed to doing our part to provide scientific and regulatory clarity for sponsors seeking to develop complex generics, as well as prioritize the approval of medicines with little or no generic competition,” Gottlieb said. This effort is part of the administration’s overarching aim to “remove barriers to generic development,” as outlined in its Drug Competition Action Plan, announced last year. “We’re especially committed to the development of generic copies of complex products,” Gottlieb said. “These products can be hard to copy, and therefore sometimes don’t face timely generic competition once patents and exclusivities are no longer a block to approval.” He added that “we’re advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritizing review of many complex generic drug applications.” What this means for back-to-school planning Before the new generic, the only other FDA-approved alternatives to EpiPen were the brand products Auvi-Q and Adrenaclick. The newly approved option made by Teva is the only approved non-brand option. The American Academy of Allergy, Asthma, and Immunology is “very pleased” with the approval of the new generic, said Dr. Robert Wood, president of the academy and director of pediatric allergy and immunology at Johns Hopkins Medicine in Baltimore. Get CNN Health's weekly newsletter Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team. “Any measures that can improve the availability and costs of these medications is a real benefit for our patients,” Wood said. “There have been recent concerns about shortages of EpiPens, which has been especially an issue as families are refilling prescriptions for back-to-school planning,” he said. “We strongly support any measures than can help provide these lifesaving medications in a more cost-effective manner, especially given the concerns about the shortages of EpiPens.”<doc-sep>
The EpiPen is getting a fresh dose of competition. The Food and Drug Administration on Thursday approved what it described as the first official generic version of the EpiPen, a life-saving treatment for severe allergic reactions. The generic device's seller, Teva Pharmaceuticals, is a rival to drugmaker Mylan's brand-name version. Mylan came under scrutiny in 2016 for a series of EpiPen price hikes. Soon after that, the company introduced what the FDA classifies as an "authorized generic" version of the EpiPen, which delivers an emergency injection of epinephrine to counteract anaphylaxis. The Trump administration on Thursday described the go-ahead for Teva as reflective of its commitment to speeding up the pace of FDA approvals. "This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages," FDA Commissioner Scott Gottlieb said in a statement. More:EpiPen up for sale? Pharmaceutical maker Mylan considering 'alternatives' More:Mylan's generic EpiPen hits market after fury over dramatic price hikes More:Mylan to pay $465M settlement over EpiPen, cuts earnings outlook Teva said the treatment's approval "marks an important step forward in bringing our patients additional prescription medications that have met the FDA’s rigorous standards. We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market." A Mylan spokesperson was also not immediately available for comment. The company announced last week that it's considering a significant shift in corporate strategy that could ultimately lead to a sale. Critics have cited Mylan as an example of exorbitant price increases that are becoming rampant in the pharmaceutical industry. Mylan repeatedly defended its moves during the crisis but also introduced discounts and the authorized generic version. It also eventually agreed to a $465 million federal settlement after investigators concluded the drugmaker overcharged the government for the treatment. The drugmaker raised EpiPen prices by roughly 400% between 2010 and 2016, according to federal investigators. Follow USA TODAY reporter Nathan Bomey on Twitter @NathanBomey.