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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 victims' families and survivors of the Florida high school shooting have not held back, calling out the National Rifle Association in the days since the massacre.On Wednesday, Dana Loesch, the organization's national spokeswoman faced them for the first time.Loesch said the organization feels the process for buying firearms is flawed and ensured the audience that the NRA is fighting for them. But the crowd booed as she left the event. 456
The United States plans to end enhanced health screening of travelers from certain countries next week, and those visitors will no longer be funneled through 15 large U.S. airports.Those requirements were imposed in January to prevent the spread of COVID-19. The Centers for Disease Control and Prevention said the government will remove those edicts beginning Monday.The CDC said the current screening, which includes temperature checks and questioning travelers about COVID-19 symptoms, “has limited effectiveness” because some infected people have no symptoms or only minor ones. Travelers go through customs only after the health screening.The health agency said that of the 675,000 travelers who went through the process, fewer than 15 were found to have COVID-19 because of the extra screening.The health agency said that instead it will focus on other measures, including a stronger response to reports of illness at airports, collecting passenger-contact electronically to avoid long lines, and “potential testing to reduce the risk of travel-related transmission” of the virus.The extra health screening applies to people who have been in China, Iran, most countries in continental Europe, the United Kingdom, Ireland and Brazil. Most people coming from those countries who aren’t U.S. citizens have been barred entry to the country.The Homeland Security Department did not immediately respond to a request for comment Thursday.A trade group representing the nation’s largest carriers praised the change.“We continue to support spending scarce screening resources where they can best be utilized,” Airlines for America said in a statement Thursday, “and, given the extremely low number of passengers identified by the CDC as potentially having a health issue, agree that it no longer makes sense to continue screening at these airports.”Separately, 18 travel and airline groups asked the administration to start pre-flight virus testing as a way to reopen international travel. The groups argue that more screening could allow countries to lift travel restrictions and quarantines that have shut down most travel between the U.S. and Europe.Airlines including Delta and Southwest have lobbied the Transportation Security Administration to screen passengers for fever before allowing them on flights within the United States. However, the CDC questioned the usefulness of temperature screening because of the large number of infected people who do not have fevers, and no widespread screening of domestic passengers was launched.___This story has been updated to read that screening began at some airports in January, not February.___This story has been corrected to note that the COVID-19 health screening began at some airports in January, not February. 2771
The U.S. has now seen two straight weeks in which at least 100,000 people are confirmed to have contracted COVID-19 each day.On Monday, the U.S. reported 166,000 new cases of the virus, marking the 14th consecutive day with 100,000 or more new cases of the virus, according to a database kept by Johns Hopkins University.The last day new cases totaled less than 100,000 was on Nov. 2. Since then, about 1.9 million Americans have contracted the virus, the rolling 7-day average of hospitalizations across the country has increased from 50,000 to 65,000 and daily deaths on a rolling 7-day average have ticked up from 824 a day to 1,114 a day.That 14-day time span has also seen seven days in which record numbers of new cases were reported. The current record was set on Friday when 177,000 people in the U.S. were confirmed to have contracted COVID-19.The current spike in caseloads has led hospitals across the country to become inundated with patients, overwhelming resources. The COVID Tracking Project reports that most of those hospitalizations are occurring in the Midwest, where rural hospitals in places like Iowa and South Dakota are running short on bed space.The current standard was predicted in June by Dr. Anthony Fauci, the nation's highest-ranking infectious disease expert. During a Senate hearing, Fauci stunned lawmakers by predicting that the U.S. could reach a point where 100,000 people were being infected each day if "disturbing trends" continued.Fauci's comments in June came during a summer spike in cases which saw infection rates top out at about 77,000 new cases each day.The current spike in cases comes as drugmakers like Pfizer and Moderna have reported encouraging results in vaccine trial results. While both vaccine candidates are on track for Emergency Use Authorization by the end of 2020, the drug likely won't be widely available to the general public for several months — Fauci has predicted that a vaccine will be widely available in the U.S. by April. 2002
The student shot at a North Carolina high school Monday morning has died, police say.The shooting occurred in a Butler High School hallway and stemmed from a fight between the victim and the suspect, said Stason Tyrrell, Patrol Commander for the Matthews Police Department.The suspected shooter, also a student, is in custody, Tyrrell said.No one else was injured.Parents were able to pick up their children, but classes resumed in the afternoon for students wishing to stay, said Yaviri Escalera, spokeswoman for Charlotte-Mecklenberg Schools.Matthews is located about 22 miles southeast of Charlotte.The-CNN-Wire 622