U.S. regulators cleared the first generic competitor to Mylan's EpiPen, after a yearslong delay that many said contributed to the emergency allergy drug's rapid rise in price. 
 
 Teva Pharmaceuticals received Food and Drug Administration approval for generic versions of both the EpiPen and EpiPen Jr, the agency said in a statement Thursday. 
 
 The products are the first competitors cleared by the FDA that are direct generic copies of the EpiPen and could be substituted for the brand-name product by a pharmacist. Other versions of epinephrine auto-injectors, such as the Adrenaclick and Auvi-Q, are on the market, but aren't considered EpiPen generics. 
 
 Teva shares rose nearly 6 percent on the news. 
 
 "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 the statement. 
 
 It may be an especially welcome time for a new entrant into the market, as the EpiPen has been facing supply issues, according to Mylan and Pfizer, which makes the EpiPen in a partnership with Mylan. 
 
 "We're applying our full resources to this important launch in the coming months and eager to being supplying the market," Teva said in a statement. The company didn't provide any details about specific timing or the planned price. 
 
 Mylan introduced its own authorized generic form of the EpiPen in late 2016, after an uproar about the branded version's price, which rose more than 400 percent over a decade. The authorized generic, identical to the original except without the brand name, cost half the price: $300 for a two-pack. 
 
 Mylan wasn't immediately available to comment on the FDA's decision. 
 
 Teva could seek to compete by pricing its generic version even lower; typically, it takes multiple generic copies of a medicine entering the market to see prices collapse substantially. 
 
 The Israeli company's application for a generic EpiPen was rejected by the FDA in early 2016, not long before the rising price of Mylan's product exploded into a major news story heading into back-to-school season, when parents often stock up for kids with allergies. 
 
 Though the key ingredient in the EpiPen, epinephrine, has been available for decades and is no longer covered by a patent, generic copies of the device have struggled to reach the market because the product is technically a drug-device combination, and the delivery device proved hard for generic competitors to copy to a degree that would satisfy regulators. 
 
 The FDA issued guidance in November 2017 to try to make it easier for generic copies of complex medicines like the EpiPen to reach the market, saying some design differences may be approved as substitutable products, as long as those differences don't affect patients' ability to use the product the way it's intended. 
 
 The FDA said Teva's generic products are expected to produce the same clinical effect and have the same safety profile as the EpiPen and EpiPen Jr. There are small differences in design, the regulator said, but they won't affect safety or efficacy. ||||| Breaking News Emails Get breaking news alerts and special reports. The news and stories that matter, delivered weekday mornings. 
 
 / Updated By Ben Popken 
 
 The cost of saving your child's life has gotten a lot more expensive. 
 
 Parents getting ready for back-to-school season have another item to toss in the basket along with Trapper Keepers and boxes of pencils — and they're facing sticker shock at the latest price increase. 
 
 Doctors and patients say the Mylan pharmaceutical company has jacked up the prices for an EpiPen — the portable device that can stop a potentially life-threatening allergic reaction — from around $100 in 2008 to $500 and up today. 
 
 That's a hike of over 400 percent. 
 
 Mylan didn't invent the EpiPen, it acquired it in 2007, getting a drug that had been approved since 1987 and had 90 percent market dominance. Nor does it manufacture the EpiPen itself. Mylan buys it from a wholly owned Pfizer subsidiary for $34.50 per pen. 
 
 Then in 2009, Mylan launched an upgraded device. A medical device technology expert and a doctor who took apart the "before" and "after" versions of the EpiPen found that despite safety and graphics upgrades, the auto-injectors shared a similar "core." 
 
 Now former pharmaceutical executive Martin Shkreli has weighed in, calling the Mylan company "vultures." 
 
 U.S. Senators are scrutinizing the price hikes, with one calling for an FTC probe. Connecticut Senator Richard Bluemnthal, who pushed for emergency epinephrine to be stocked in public schools, pledged Friday to investigate the "shocking increase." 
 
 UPDATE: On 9/21/16, the House Oversight Committee grilled Mylan and the FDA in a hearing on the EpiPen price hike. 
 
 "Patients are calling and saying they can't afford it," said Dr. Douglas McMahon, an allergy specialist in Maplewood, Minnesota. "They're between a rock and a hard place." 
 
 Following a recall by Mylan's chief competitor last year, the company now enjoys a near monopoly. 
 
 Because of aggressive marketing and branding campaigns, and lobbying for legislation that requires the product to be stocked in schools, they have a brand dominance equal to that of Kleenex, doctors say. 
 
 About the size of a fat marker, they are carried by many parents of kids with severe allergies wherever they go — ready to jam the gizmo into their child's thigh to deliver epinephrine and stop anaphylactic shock from a potentially fatal bee sting or bit of peanut. 
 
 An EpiPen. Carlos Osorio / AP file 
 
 And because they have a stated expiration date of one year, parents refill them annually, incurring an additional co-pay each time. 
 
 Tracy Bush, a 42-year-old mom and food allergy consultant, never goes anywhere without two EpiPens on her. Her son, age 14, carries another. She began doing so after he was diagnosed with severe allergies as a 2-year-old. 
 
 For the past 10 years, she has watched the price she paid for her refills rise higher and higher with no discernible improvement to the device or medicine. 
 
 In 2008, Bush said the price was $145.99. In 2010, it was $220.99, then jumped to $649.99. This year her pre-insurance costs were $1,118.08. 
 
 Despite the hikes, Bush was glad to have the device two years ago when her son had a bad reaction while eating some watermelon. 
 
 "He said it felt like a potato chip was caught in his throat. Then he got a look of terror on his face. His voice was totally different, it sounded like he had sucked helium. I was like 'Oh my goodness, I'm going to have to use an EpiPen,'" she said. "I will never forget the look that I saw." 
 
 In a statement, Mylan said that the prices have "changed over time to better reflect important product features and the value the product provides," and that "we've made a significant investment to support the device over the past years." 
 
 The company also offers coupons on its website that can reduce costs. This year, for the first time, Bush was able to use those coupons and her "good" insurance plan to bring down her out-of-pocket costs to zero. But not everyone can do the same. 
 
 "When epinephrine only costs a few cents, but they're going up to $500, personally I don't think that's ethically responsible," said Dr. McMahon. 
 
 And he understands better than most what costs are involved: For the past few years he's been developing his own, smaller version of the EpiPen, and trying to get it approved by the FDA and bring it to market. He estimates that process costs about $1.5 million. In 2015, Mylan's profits from the sale of EpiPens rose to $1.2 billion. 
 
 McMahon says his device will retail for about $50. 
 
 Vermont Sen. Bernie Sanders, the former presidential contender and a member of the Senate Committee on Health, Education, Labor and Pensions, told NBC News in a statement: 
 
 "The drug industry's greed knows no bounds. There's no reason an EpiPen, which costs Mylan just a few dollars to make, should cost families more than $600. The only explanation for Mylan raising the price by six times since 2009 is that the company values profits more than the lives of millions of Americans." ||||| Sarah Jessica Parker attends the 2016 PEN America Literary Gala. Credit: J. Countess/Getty Images 
 
 Sarah Jessica Parker has cut ties with Mylan, the manufacturer of EpiPen, a portable injector that can stop a life-threatening allergic reaction. Her reason: The company has steadily increased the price for a pack of two from around $100 in 2007 to more than $600 in recent years, a hike of more than 400 percent. 
 
 “I’m left disappointed, saddened and deeply concerned by Mylan’s actions,” the former Sex and the City star, 51, wrote in an Instagram post on Thursday, August 25. “I do not condone this decision and I have ended my relationship with Mylan as a direct result of it.” 
 
 She continued, “I hope they will seriously reconsider the outpouring of voices of those millions of people who are dependent on the device, and take swift action to lower the cost to be more affordable for whom it is a life-saving necessity.” 
 
 A photo posted by SJP (@sarahjessicaparker) on Aug 25, 2016 at 4:02am PDT 
 
 According to The New York Times, Mylan has imposed two 15 percent increases a year for the past few years. 
 
 
 
 Parker had been a paid spokesperson for Mylan in May and spoke to Us Weekly about her 13-year-old son James Wilkie’s life-threatening peanut allergy and revealed that he carried two EpiPens. In the interview, Parker told Us she was surprised to learn that 43 million Americans are at risk for anaphylaxis, and every six minutes, food allergy reactions send someone to the emergency room. 
 
 
 
 Meanwhile, the Emmy winner isn’t the only famous face taking aim at Mylan. Democratic presidential nominee Hillary Clinton released a statement on Wednesday, August 24, in which she called the price hikes “outrageous, and just the latest example of a company taking advantage of its consumers.” 
 
 “It’s wrong when drug companies put profits ahead of patients, raising prices without justifying the value behind them,” Clinton, 68, said. 
 
 On Thursday, Mylan announced the company will be offering coupons covering up to $300 “for patients in health plans who face higher out-of-pocket costs.” 
 
 “As a mother, I can assure you, the last thing that we would ever want is no one to have their EpiPen due to price,” Mylan CEO Heather Bresch said in an interview with CNBC Thursday. “Our response has been to take that immediate action making sure everyone has an EpiPen.” 
 
 Bresch defended the price hike by pointing to the marketing and distribution costs of EpiPens. 
 
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– Parents of children with serious allergies may soon get some relief when shelling out for a epinephrine auto-injector. The FDA has approved a generic alternative to Mylan Pharmaceuticals' widely used EpiPen and EpiPen Jr., reports CNN. While other name-brand injectors exist, this one, produced by Teva, is the first approved non-brand option. "This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option," FDA chief Scott Gottlieb, "as well as another approved product to help protect against potential drug shortages." As the AP notes, Mylan caught serious heat in 2016 when it jacked up the price of a two-pack to $600, or five times what it cost 10 years before. Israel-based Teva says it plans to launch the product as soon as possible, though it provided no specifics about a date or a possible price. Mylan has its own generic version of the device on the market for $300 per two-pack, and CNBC says the price probably won't drop substantially below that until multiple approved generics hit the market. (Mylan's CEO had to fend off comparisons to Martin Shkreli.)