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The US Food and Drug Administration on Thursday announced the approval of?the first generic version of EpiPen.The auto-injector pen delivers the drug epinephrine to patients experiencing a severe allergic reaction that, if untreated, could develop into the life-threatening condition of anaphylaxis. The medication is delivered into a muscle as a single dose, like a shot, through an injector pen with a spring.Allergies from food, bug bites, medications and latex can cause life-threatening reactions.The newly approved generic is made by Teva Pharmaceuticals and offers an alternative for patients who, until now, have been able to use only the brand-name EpiPen made by Mylan. It is approved in a smaller dose for children, as well.There are two other brand products on the market for a severe allergic reaction: Adrenaclick and Auvi-Q.The newly approved option made by Teva is the only approved non-brand option and can be substituted only for Mylan's 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 a statement announcing the approval.In recent years, Mylan came under fire for a price increase that put the product out of reach for many who needed to keep the drug on hand. 1488
The US will respond to the Assad regime's alleged chemical attack against Syrian civilians, US Ambassador Nikki Haley told the United Nations as she excoriated Russia, saying its hands are "covered in the blood of Syrian children.""Chemical weapons have once again been used on Syrian men, women and children," Haley said at a special meeting of the United Nations Security Council to discuss what appeared to be a chemical attack on Douma, the last rebel-held town in Syria, on Saturday that left 49 people dead and scores injured."History will record this as the moment when the Security Council either discharged its duty or demonstrated its utter and complete failure to protect the people of Syria," Haley said. "Either way, the United States will respond."Images of gasping children struggling to breathe shocked the world and galvanized President Donald Trump, who condemned the attack as "sick" and upbraided Russian President Vladimir Putin and Iran for supporting Syrian President Bashar al-Assad.Trump threatened that there would be "a big price to pay" for the attack.On Monday, Haley made clear that Russia could "pay" as well, as tensions between Washington and Moscow were laid bare in the Security Council. Russia's ambassador accused the US of plotting against Moscow and Syria, threatening international security, stoking global tensions and operating outside the confines of international law.Haley described at length and in detail blue-skinned Syrian toddlers lying dead in their parents' arms after the suspected chemical attack and made clear that the US sees Moscow as responsible. Russia, she implied, is not even a civilized nation."The monster who was responsible for these attacks has no conscience to be shocked by pictures of dead children," Haley said, explaining that she wouldn't show photos of the victims as she had after a chemical attack in April 2017 that led to US strikes on Syria."The Russian regime, whose hands are also covered in the blood of Syrian children, cannot be shamed by pictures of its victims," she said. "We've tried that before.""Russia could stop this senseless slaughter, if it wanted," she said. "But it stands with the Assad regime and supports it without hesitation. What's the point of trying to shame such people? After all, no civilized government would have anything to do with Assad's murderous regime.""Russia's obstructionism will not continue to hold us hostage when we are confronted with an attack like this one," she added.Russia pushed back hard. "Nobody has invested you with the authority to act as gendarmes, policemen of the world ... we call on you to return to the legal fold," Ambassador Vassily Nebenzia said. Earlier, Russian Foreign Minister Sergey Lavrov had argued that there is no evidence chemical weapons were used, a claim Nebenzia echoed."The use of sarin and chlorine is not confirmed," Nebenzia echoed in the Monday meeting. He went on to say that the US, along with the UK and France, is acting "without any justifications, and without considering the consequences have engaged in a confrontational policy toward Russia and Syria."In extended, rambling remarks, Nebenzia accused the US of plotting a strike against Damascus and planting the "fake news" of the Douma attack Saturday as justification. He then veered off onto the subject of an alleged nerve agent attack on a former Russian spy in the UK, attempting to link all the events."Is it not clear to all? Syria, Russia, Salisbury," Nebenzia said, referring to the British city where the spy was poisoned.The UN's special envoy for Syria, Staffan di Mistura, noted that some states have publicly raised their suspicions that Syria was behind the attack. Other states, he said, "have strongly questioned the credibility of these allegations.""What reason more, then, for a thorough, independent investigation," he concluded, as he denounced the use of chemical weapons as "abhorrent" and called for a thorough investigation.Nongovernmental organizations on the ground had documented "hundreds of cases of civilians with symptoms consistent with exposure to chemical weapons," he said.Between August 2013 and February 2018 there have been at least 85 confirmed chemical attacks in Syria, with the Syrian government responsible for at least 50 of them, according to Human Rights Watch.Even before Nebenzia's accusations, Mistura warned about the hostilities in Syria spiraling out of control to threaten international stability. "I have reached a point in which I am expressing a concern about international security," he told the council.Telling the gathered officials that recent developments carry more danger than ever, he said that "different fault lines that are completely crossing each other and are interconnected" and escalation could "have absolutely devastating consequences that is difficult for us to even imagine.""The council cannot allow a situation of uncontrollable escalation in Syria on any front," he said.Haley and other speakers stressed that a dangerous precedent is being set."We are on the edge of a dangerous precipice," Haley said. "The great evil of chemical weapons use that once unified the world in opposition is on the verge of becoming the new normal. The international community must not let this happen." 5312

The revolving door of USA Gymnastics' top leadership keeps spinning as the organization struggles to recover from the Larry Nassar scandal.Less than a week after taking over USAG, former US Rep. Mary Bono has resigned as interim president. That means four high-ranking officials have left USAG in the past six months -- even though most came on board after the Nassar sex abuse scandal.Bono took the helm just a month after embattled president and CEO Kerry Perry quit. Perry, who had only been on the job for nine months, was criticized for what many considered to be inadequate action and boilerplate soundbites during the Nassar abuse fallout.On Tuesday, four days after she started her new job, Bono announced her resignation."It is with profound regret, coupled with a deep love for the sport of gymnastics and respect for those who aspire to be great gymnasts, that I today tendered my resignation as the interim CEO of USA Gymnastics," Bono said in a statement. 976
The U.S. government is officially investigating Facebook.The Federal Trade Commission confirmed in a statement Monday that it is currently investigating Facebook data practices as the company faces new scrutiny from the Cambridge Analytica scandal."The FTC takes very seriously recent press reports raising substantial concerns about the privacy practices of Facebook," said Tom Pahl, acting director of the FTC's Bureau of Consumer Protection. "Today, the FTC is confirming that it has an open non-public investigation into these practices."News broke earlier this month that Cambridge Analytica, a data firm with ties to President Donald Trump's campaign, reportedly accessed information from about 50 million Facebook users without their knowledge.CNN reported last week that the FTC was sending a letter to Facebook with questions about how the social media company allowed the data to wind up in the hands of Trump campaign consultants.Facebook stock was down 4% in early trading Monday.Reps for Facebook did not immediately respond to a request for comment. 1077
The woman who became internet famous in October for flipping the bird at President Donald Trump's motorcade, and then said she was subsequently fired, is suing her former employer for unlawful termination.Juli Briskman was fired from the marketing team at Akima LLC in November shortly after she volunteered that she was the one who had made the gesture in a photo that went viral, she said at the time."I thought that it would probably get back to my company eventually," Briskman said in an interview with CNN's Jeanne Moos.She said she was told she had violated the company's social media policy, and said the company in turn fired her.Briskman tweeted Wednesday that "I was fired from my job for flipping off @realDonaldTrump. Today, I filed suit with @GellerLawyers & @protctdemocracy because what happened to me was unlawful and un-American."Her attorney, Maria Simon, reiterated this point in a statement through the nonprofit Protect Democracy,"Juli's expression of disapproval of the President is fundamental political speech protected by both the United States Constitution and Virginia state law," she said. "Akima's actions -- forcing Juli to resign out of fear of unlawful retaliation by the government -- violated the basic tenets of Virginia employment law. Ms. Briskman chose in her private time and in her capacity as a private citizen to express her disapproval of President Trump by extending her middle finger."CNN has reached out to Akima LLC seeking comment. 1512
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