FDA Approves First Generic EpiPen

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

The Food and Drug Administration has approved the first identical alternative to the EpiPen, which is widely used to save children and adults suffering from unsafe allergic reactions. Food and Drug Administration gave approval Thursday for the first generic version of EpiPen, an injection device to treat severe allergic reactions.

The drug is automatically injected into a person's thigh to stop an allergic reaction, the symptoms of which typically include dizziness, vomiting and difficulty breathing. Consumers and lawmakers have been clamoring for a generic version of the EpiPen ever since its manufacturer, Mylan, drastically hiked the price more than 400 percent in less than a decade.

Teva's American depositary receipts rose 7.1 per cent to US$24.06 at 1:02 p.m.in NY.

US -listed shares of Teva jumped 6 percent to $23.88, while those of Mylan were down 1.3 percent at $37.31.

"Today's approval.is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives", FDA Commissioner Scott Gottlieb said in a statement.

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 a year ago.

Читайте также: Google adds Confidential mode to Gmail app

Mylan acquired the rights to sell EpiPen in 2007, when it cost about US$57 per shot. In August 2016, Mylan Pharmaceuticals was criticized for raising the price of a two-pack of EpiPens to $600.

Epinephrine alone is already a generic drug and the dose in an auto-injector costs less than a dollar to make.

The FDA has previously approved competitors to Mylan's EpiPen under new drug applications, such as Amedra Pharmaceuticals' Adrenaclick and Kaleo's Auvi-Q.

"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. (Typically, generics can be automatically substituted for the brand name by a pharmacist.) The two rivals haven't sold almost as well as EpiPen without name recognition.

Back in May the FDA also declared a shortage of EpiPens available in the U.S. In addition, Mylan launched an "authorized generic" version of EpiPen in 2016. He pointed out that Mylan now has about 73.5% of the epinephrine market, with its branded EpiPen at approximately 24.7% and its own generic at 48.7%.

Mylan's cap is nonremovable, a fairly recent innovation that prevents users from accidentally pricking themselves or others.

При любом использовании материалов сайта и дочерних проектов, гиперссылка на обязательна.
«» 2007 - 2019 Copyright.
Автоматизированное извлечение информации сайта запрещено.

Код для вставки в блог

Related:

  • Premier League referee quits — Bobby Madley

    Premier League referee quits — Bobby Madley

    The circumstances around his departure are unclear, but it is thought it could be linked to a video posted on social media. Last season he officiated high profile matches between Manchester United and Chelsea, and Liverpool and Arsenal.
    Nasir Jamshed banned for 10 years in PSL spot-fixing case

    Nasir Jamshed banned for 10 years in PSL spot-fixing case

    The other four cricketers Sharjeel Khan , Khalid Latif, Shahzaib Hasan and Muhammad Irfan had served their respective punishments. Rizvi said that even if Jamshed returned from his 10-year ban, he will not be engaged in any cricket management role.
    Ariana Grande Pays Tribute to Aretha Franklin With Moving Performance

    Ariana Grande Pays Tribute to Aretha Franklin With Moving Performance

    A host of celebrities have paid tribute to Franklin , including songwriter Carole King, Barbara Streisand, Diana Ross and Elton John.
  • Paul Pogba transfer: Jose Mourinho 'never so happy' with Man Utd star

    Paul Pogba transfer: Jose Mourinho 'never so happy' with Man Utd star

    Speaking to Paddy Power, Ince was quick to jump on the media bandwagon and lay into Pogba, who he believes has "too much to say". Pogba stood his ground in the meeting and told Mourinho that if he wanted to speak that way to him he should go via Raiola.
    Priyanka Chopra’s family to host engagement party

    Priyanka Chopra’s family to host engagement party

    The rock on PC's finger has made enough headlines, more so after pictures from Manish Malhotra's party came out. Priyanka and Nick , who reportedly dated for two months, were first spotted together at the 2017 Met Gala.
    40 children killed in Yemen bus strike

    40 children killed in Yemen bus strike

    Tens of thousands of Yemenis have been injured and martyred in Saudi-led strikes, with the vast majority of them are civilians. The International Committee of the Red Cross reported the same toll on Friday, citing authorities in Saada .
  • STAR WARS RESISTANCE Premiere Date & Pilot Synopsis

    STAR WARS RESISTANCE Premiere Date & Pilot Synopsis

    New details have arrived along with the trailer, which teases the one-hour premiere titled "The Recruit". Disney XD's Star Wars Resistance will debut October 7 at 10:00 p.m.
    Deontay Wilder gatecrashes Tyson Fury weigh-in to trade insults with rival

    Deontay Wilder gatecrashes Tyson Fury weigh-in to trade insults with rival

    The bout is priced very similarly to a potential Anthony Joshua fight with Fury available at EVENS and Joshua at 4/5. An announcement could come as soon as that point, but if not, it is likely to be confirmed in the days following.
    Tiny Harris Posts A Gorgeous Throwback Pic Featuring Herself And Aretha Franklin

    Tiny Harris Posts A Gorgeous Throwback Pic Featuring Herself And Aretha Franklin

    The singer tweeted, "I am deeply saddened about the passing of the Queen of Soul and my sister in song, Aretha Franklin. In a career crossing generations, her hits spanned from soul and R&B, to gospel and pop.
  • Pochettino reiterates his commitment to Tottenham Hotspur

    Pochettino reiterates his commitment to Tottenham Hotspur

    The forthcoming match is Tottenham's second of the season, but their first at their temporary home of Wembley Stadium. I don't believe there will be too much movement because we cannot sign, but different individual things can happen.
    Stormy Daniels explains Celebrity Big Brother exit

    Stormy Daniels explains Celebrity Big Brother exit

    Earlier today The Sun reported that the 39-year-old pulled out of CBB's live launch last night following a "furious bust up with producers".
    Imran Khan elected new Prime Minister of Pakistan

    Imran Khan elected new Prime Minister of Pakistan

    This happened after more than two decades since the former captain of the Pakistan cricket team entered politics. He was jailed in the lead-up to the vote, and his brother, Shahbaz Sharif, led the PML-N party into the election.

Comments

Latest news

Sergio Ramos: Real Madrid will win again, no one will doubt it
On top of that, Real have just sold their best and arguably greatest ever player as Cristiano Ronaldo joined Juventus for €100 million.

WaPo columnist calls on GOP to censure Trump over security clearances
Trump has tweeted about to highlight his assertions of political bias behind the Russian Federation investigation. He said he was fine with giving Brennan a bigger voice because he enjoyed tackling with critics.

Scarlett Johansson Highest Paid Actress 2018
Angelina Jolie returned to the list, largely helped by an advance payment for her future role in Maleficent 2 . Scarlett Johansson was last seen playing Black Widow in this yera's blockbuster film Avengers: infinity War .

Rail unions are to blame for fare hikes, Chris Grayling suggests
Chris Grayling, the Transport Secretary, wants to pin fare rises to the lower rate of CPI, which now stands at 2.3 per cent. Passenger groups, unions and politicians reacted with anger after the cap on regulated fare rises was confirmed.

Manchester City's Kevin De Bruyne out for three months with knee injury
De Bruyne suffered a similar setback in the 2015/16 season, missing two months then after tearing ligaments in his knee and ankle. He was a second-half substitute in the 2-0 Premier League-opening victory over Arsenal on Sunday, coming on in the 60th minute.

Turkish lira volatile as United States warns of further sanctions
And for the second time this week, a Turkish court on Friday rejected Brunson's appeal to be released . President Erdogan has urged Turks to shore up the currency by not trading in dollars and euros.

Dr Bumbum, Brazil plastic surgeon, charged with murder
Prosecutors said Maria Fatima Barros presented herself as a doctor, but her medical licence to practice in Rio had been suspended. The lawyer for Dr Furtado said her client was innocent and had not turned himself in to police because he was in a panic.

China 'training for strikes' on USA and its allies
U.S. intelligence has raised concerns over China's growing influence in the Pacific, a stronghold of the United States for years. The Trump administration is also mulling a Space Force in order to counter threats in space from countries including China.

Woods at best in majors with lead
His best shot over a final round of 4-under 66 was a lasered 4-iron to the 16th green that landed 6 feet away and set up a birdie. The British Open gets the distinction of being the only major this year where a significant scoring record was not set or tied.

US sanctions China, Russia firms for helping NK illicit shipments
Mnuchin said the designations will remain in place until the fully verified denuclearization of North Korea has taken place.

Google employees sign protest letter over China search engine
Disclosure of the secretive effort has disturbed some Google employees and human rights advocacy organizations. The first two questions from staff members at Google's Thursday meeting were about Dragonfly, the people said.

World's oldest cheese found in Egyptian tomb
This potentially deadly disease spreads from animals to people, typically from eating unpasteurized dairy products. To date, only indirect signs of brucellosis have been discovered on Egyptian bones that date back to 750 BCE.

Musk's SpaceX could help fund take-private deal for Tesla
The billionaire was forced to apologise to a British diver who helped to rescue the boys after Musk labelled him " pedo guy ". Musk and officials with Tesla's board plan to meet with SEC officials next week, according to the Times .

Liverpool's Ragnar Klavan flying to Italy to complete £2m move to Cagliari
And, ahead of Real's UEFA Super Cup clash with Atletico Madrid on Wednesday, Ramos chose to open fire on Klopp's losing record in cup finals.

Verizon to offer free Apple TV 4K with wireless 5G residential broadband
Verizon's 5g network will launch in 4 major markets to start out with: Sacramento , Los Angeles , Houston and Indianapolis. As mobile devices become available in early 2019, Verizon plans to quickly move to be first in 5G mobile service.

Other news