FDA approves generic version of EpiPen

EpiPens have been in short supply for months but the problem became especially acute with back-to-school season

"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 released statement.

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. In step, Mylan CEO Heather Bresch saw her salary soar by millions, reaching almost $19 million in 2015-a point lawmakers hammered her for during a House Oversight committee hearing in September of 2016.

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 anaphylaxis. 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.

The Food and Drug Administration approved the first generic versions of Mylan's EpiPen on Thursday, opening the door for a cheaper and possibly more widely available treatment for life-threatening allergic reactions.

Teva's generic will compete against Mylan's own authorized generic, which already has steeply eroded its brand-name sales. But the EpiPen is a drug-device "combination product", which has been tricky for rivals to replicate exactly in order to get FDA approval.

The newly approved option made by Teva is the only approved non-brand option and can be substituted only for Mylan's EpiPen.

Mylan has also been facing supply issues.

Trump expects to ‘quickly’ revoke Bruce Ohr’s security clearance
He also said that Special Counsel Robert Mueller was conflicted but said he was willing to allow the investigation to continue. The only question remaining is whether the collusion amounts to a "constituted criminally liable conspiracy, " Brennan wrote.

SEC reportedly began Tesla probe past year
The company could face sanctions if regulators find it misled investors about production delays. Musk told the Times that board members had not complained to him about his tweet.

Ariana Grande Performs Emotional Tribute To Aretha Franklin On ‘The Tonight Show’
Over on The Late Show , host Stephen Colbert reminisced about watching Franklin perform at the 2015 Kennedy Center Honors. TMZ report that after she finished the song, Ariana left the stage and broke down in tears.

Teva's bid to sell a generic EpiPen faced multiple setbacks at the FDA, which rejected the company's initial application in 2016. After drawing fire from patients and politicians, Mylan offered a generic version of its device for about half the price.

Still, Teva has yet to name the price of its generic, ensuring that the FDA's hopes are indeed true.

The price of two EpiPens was about $100 in 2009.

The agency granted the approval to Teva Pharmaceuticals to create generic versions of both the standard auto-injector and the EpiPen Jr. for children.

In an emailed statement, a Teva spokesperson said: "We're applying our full resources to this important launch in the coming months and eager to begin supplying the market".

Teva did not respond to questions about how much its generic version will cost, or when it will become available.

Related News:

  • U.S.  threatens more Turkey sanctions if pastor not freed

    U.S. threatens more Turkey sanctions if pastor not freed

    Meanwhile, Turkish people in social media tend to expand boycott in other US products ranging from textile to fast food. The crisis has been precipitated by investor alarm about President Tayyip Erdogan's influence over monetary policy.
    Aretha Franklin: A life in pictures

    Aretha Franklin: A life in pictures

    Other hits include "Day Dreaming" (1972), "Jump to It" (1982), " Freeway of Love " (1985), and "A Rose Is Still A Rose" (1998). She had battled health issues in recent years and in 2017 announced her retirement from touring.
    The Eagles used lockers to subtly troll the Patriots

    The Eagles used lockers to subtly troll the Patriots

    After the game, Eagles Coach Doug Pederson said he would wait for a medial evaluation before offering more details on the injury. The hit knocked Foles out of the game. "I wouldn't be a bad sport". "I know how hard it is to win that last game".
  • Scarlett Johansson tops highest-paid actress list for 2018

    Scarlett Johansson tops highest-paid actress list for 2018

    Johansson takes over the top spot from previous holder, Emma Stone, who held the title a year ago after earning $26 million. She claims fourth place with $18 million for her role in the upcoming X-Men: Dark Phoenix as well as her contract with Dior.
    Google promises a fix to solve Pixel charging issue on Android 9

    Google promises a fix to solve Pixel charging issue on Android 9

    Google has confirmed it is working on a fix for a fast charging issue affecting some Pixel handsets since downloading Android Pie. The move was put in place to comply with regional laws that required consent from both parties for a call to be recorded.
    Sergio Ramos Criticizes Jurgen Klopp as UCL Final Row Continues

    Sergio Ramos Criticizes Jurgen Klopp as UCL Final Row Continues

    Newcastle reportedly attempted a deadline day swoop for Klavan, while Fenerbahce were in the running until as late as Thursday. Klavan joined Liverpool from Bundesliga side Augsburg in a €5m deal in 2016 and has made 53 appearances, scoring twice.
  • Brazil's 'Dr. Bumbum' Charged With Murder After Fatal Plastic Surgery

    Furtado, who has almost 1 million followers on Instagram, is frequently on Brazilian TV screens and promises his clients beauty. The prosecutors' charges now need to be accepted by a judge before any trial can take place and penalties could reach 30 years.
    World's oldest cheese discovered in 3,200 year-old Egyptian tomb

    World's oldest cheese discovered in 3,200 year-old Egyptian tomb

    Alongside the jar, the archaeologists found a canvas cloth that they believe was used to cover or preserve the jar's contents. Despite finding the cheese , scientists have not been able to find the mummified body of Ptahmes nor the rest of his family.
    More than 70 people overdose in a single day in New Haven

    More than 70 people overdose in a single day in New Haven

    What do the police say? "It's a synthetic, a man-made product so you never know what they're putting in it", said Asst. Doctors said some victims improved after being given the opioid overdose antidote drug naxolone, while others did not.
  • Google employees sign protest letter over China search engine

    Google employees sign protest letter over China search engine

    Google pulled its servers from mainland China in 2010 over concerns with government censorship, a decision Brin primarily drove. Yet most of us only learned about project Dragonfly through news reports [in] early August .
    'Hard Knocks' shows Corey Coleman asked Browns to trade him

    'Hard Knocks' shows Corey Coleman asked Browns to trade him

    Jackson said Stanton will play in the team's preseason game Friday against Buffalo so the coaches can watch him run the offense. Tyrod Taylor won't have a chance to play the Bills this regular season since the two teams aren't on each other's schedules.
    American Legion: Trump Should Spend Money On Vets Instead Of Parade

    American Legion: Trump Should Spend Money On Vets Instead Of Parade

    US President Donald Trump requested a parade after seeing France's Bastille Day event in 2017 and expressing a desire to "top it". The defense official said that the parade would include Bradleys, as well as other armored vehicles including Strykers and M113s.


Most liked

Real Madrid v Atletico: We can't deny missing Ronaldo - Casemiro opens up
Specifically, that means a centre-forward, a central defender and a "physical midfielder". Initially, the 29-year-old looked visibly fitter and...

Mauricio Pochettino Sends Clear Message To Wantaway Tottenham Players
But the new stadium may not be completed by then and an National Football League game is being played at Wembley on that date. Of course, I understand the problems about the tickets, the money and everything, and I feel sorry for [the fans].

Nasir Jamshed banned for 10 years in PSL spot-fixing case
He has been charged of violating Articles 2.1.1, 2.1.2, 2.1.3, 2.1.4 and 2.4.4 of the PCB's Anti-Corruption Code. The ban was announced on Friday by Pakistan Cricket Board's (PCB) Anti-Corruption Tribunal.

Premier League referee quits due to 'change in personal circumstances — Bobby Madley
Madley was also on FIFA's list of officials, making him eligible to take charge of worldwide fixtures. The PGMOL had 18 referees to cover Premier League matches this season but are now limited to 17.

Nick and his parents arrive in India
The source was further quoted as saying, "Everything is very secretive but guests are expected to head there starting tomorrow". Confirmation of the Nick Jonas-Priyanka Chopra wedding comes after a couple of months of speculation over their wedding.

Tyson Fury's dad and Deontay Wilder involved in confrontation at weigh-ins
Asked for his opinion of Saturday's fight, Wilder said: "Fury's going to win, then I'm going to knock him out". He displayed his trimmed torso to a roaring audience as he scaled 18 stone 10 lbs.

De Bruyne set for three months on the sidelines
The Belgium global , a second-half substitute in Sunday's 2-0 victory over Arsenal , suffered the injury in training on Wednesday. Tests have revealed the midfielder will not require surgery but is likely to be sidelined until mid-November.

Pentagon says China military ‘likely training for strikes’ on US targets
The document also warns that China "is likely preparing for a contingency to unify Taiwan with China by force". DOD officials expect China to increase its defense budget to $240 billion over the next decade.

Google adds Gmail Confidential Mode to Android
Google has announced this morning that the feature has now gone live in the Gmail for Android app. Confidential Mode sends emails that self-destruct after a given length of time.

Stormy Daniels 'drops out of Celebrity Big Brother over money row'
The mum-of-two struggled to catch her breath as she made her way through the house - and it didn't go unnoticed by audiences. However, according to reports, the former porn star landed in London, before promptly demanding more money from producers.

US Imposes Fresh N Korea-Related Sanctions: Treasury
The Treasury Department said that the China-based Dalian Sun Moon Star International Logistics Trading Co. and SINSMS Pte. The latest sanctions were imposed amid predictions that U.S.

Imran Khan defeats Shahbaz to become Pakistan’s new Prime Minister
The PTI leader also spoke about the place Imran will be staying at if and when he is elected as the prime minister. Voting for prime minister of Pakistan begins in the National Assembly, being presided over by Speaker Asad Qaisar.

Verizon Exec: 5G to Propel Useful Tech and Streaming Partnerships
This meeting is open to the media and will be live-streamed via https://www.facebook.com/vzuptospeed/ . If you don't want that or already have a subscription, you can opt for a complimentary Apple TV 4K.

Saudi Soldiers Killed in Yemeni Retaliatory Attack
Yemeni Foreign Minister Khaled al-Yamani said on Al-Hadath channel on Monday that his government welcomed the Geneva talks. The U.S. has backed a coalition led by Saudi Arabia and the United Arab Emirates to restore the government.

Davis Cup officially overhauled for 2019 with season-ending team event
The Americans will play at Croatia in this year's semifinals in September, with Spain and France meeting in the other semifinals. Twenty-four teams would compete in home and away ties in February, with 12 winning teams advancing to the finals in November.