Economy

Mylan Gains FDA Approval for Generic Copaxone

Mylan Gains FDA Approval for Generic Copaxone

Mylan said the drug is very popular in the US, adding in its statement that the 20 mg version has brand sales of about $700 million and the stronger 40 mg dose a brand size of $3.64 billion.

Shares of Natco Pharma gained 20 per cent to hit the upper circuit of Rs 954.35 on Wednesday after its partner Mylan received the U.S. regulator's approval for the generic version of multiple-sclerosis treatment drug Copaxone. The generic version is coming to a market of about 400,000 U.S. patients with MS - 85% of whom suffer from a relapsing form.

More news: Rahul Gandhi 'unquestioned choice' for party president: Surjewala
More news: United Kingdom scientist among Nobel Prize winners for 3D molecule imaging
More news: PS4 players could have to wait even longer for PUBG

The FDA approved both doses - 20 mg and 40 mg - of Mylan's version of Teva's Copaxone, which generated global sales of $1.02 billion in the second quarter of this year.

"Mylan has invested tens of millions of dollars over many years to bring this medicine to market", CEO Heather Bresch said. Importantly, Copaxone is AP rated (or therapeutically equivalent and substitutable), which makes it easier to switch existing Copaxone patients to the generic. "Our commitment to the MS patient community extends beyond bringing generic versions of these products to market". The program includes a mobile app, in-home injection training, a round-the-clock support center, MS nurse support and co-pay assistance. "/" Class="local_link" >(NASDAQ:MYL) shot up 17.59% in NY on the back of Food and Drug Administration (FDA) approval news. The formal decision is pending FDA ruling. The potential generics represent a total of $92.5 billion in annual brand sales, according to QuintilesIMS. Also, Mylan may be eligible for 180-day exclusivity of this product, though the FDA did not indicate other entrants (namely Momenta/Sandoz) would not be able to also enter the market. Currently, one out of every 13 prescriptions filled in the US - brand-name or generic - is a Mylan product.


  • Obama interrupts Michelle's interview to celebrate 25th marriage anniversary

    Obama interrupts Michelle's interview to celebrate 25th marriage anniversary

    Obama also recalled what it meant to have a commander in chief "who upholds and respects the office" of the presidency. You don't get to have the same kind of interaction and, therefore, there are some parts of you that do lose touch.
    Liverpool want bigger Premier League TV money share

    Liverpool want bigger Premier League TV money share

    Previous year they simply couldn't get the second, but now they are adding a second, third, and fourth on a regular basis. After the October global break, Manchester United will have to show what they can do against challenging teams.
    Lock down your money after Equifax breach

    Lock down your money after Equifax breach

    It appears to be similar to credit freezing, but that process is regulated by state laws, something this service would not offer. And yet while Equifax is making money off the data breach , its potential costs are shockingly low.
  • 'Furious' Knicks Owner James Dolan Called Rupert Murdoch Over Controversial Fox Ads

    'Furious' Knicks Owner James Dolan Called Rupert Murdoch Over Controversial Fox Ads

    Three side-by-seats seats read, "Sit here if you blame Phil", "Sit here if you blame Melo", and "Sit here if you blame Dolan". ESPN's Darren Rovell , citing a team source, says the ads will be taken down by the Metropolitan Transportation Authority.
    Probe continues into possible Russian collusion with Trump campaign

    Probe continues into possible Russian collusion with Trump campaign

    Burr said Wednesday that the committee has not seen any evidence that the activities favored either Republicans or Democrats. Senate Intelligence Vice Chairman Mark Warner echoed Burr's statement.
    Women's Center kicks-off Domestic Violence Awareness Month

    Women's Center kicks-off Domestic Violence Awareness Month

    Over the past eight years, UnitedHealthcare employees have donated more than 20,000 pounds of food to Catalyst Domestic Violence. Joplin, MO- A new display is set up in the Student Center at MSSU to recognize domestic violence awareness month.
  • Electric milestone revealed by Land Rover

    Electric milestone revealed by Land Rover

    The highlight of a refreshed Range Rover Sport line-up, the new P400e, is a Range Rover like no other since the first in 1970. The P400e combines a 296bhp 2.0-litre four-cylinder Ingenium petrol unit with a 114bhp electric motor.
    Glamorous Filipino-Australian girlfriend of Las Vegas shooter Stephen Paddock

    Glamorous Filipino-Australian girlfriend of Las Vegas shooter Stephen Paddock

    The Philippines' National Bureau of Investigation (NBI) said the FBI, its U.S. counterpart, had sought help in finding Danley. Mendoza said they always ordered the same drinks - a venti mocha cappuccino for him and a medium caramel macchiato for her.
    Sunday's National Football League  games: Rams kick Cowboys; Patriots lose at home

    Sunday's National Football League games: Rams kick Cowboys; Patriots lose at home

    Indeed, Dallas will get everyone's best shot this season, and they surely got a hefty one-two punch from the revived Rams . "You get picked No. 1 for a reason and he's had a lot of success early this year, so he's good", said Prescott of Goff.
  • Redskins Josh Norman expected to miss a few weeks according to reports

    Redskins Josh Norman expected to miss a few weeks according to reports

    In addition to being a quality corner in coverage, Norman hasn't shied away from helping against the run, and he aids safety D.J. The unit dominated the Oakland Raiders in Week 3, and began Monday night by playing extremely well against the undefeated Chiefs.
    SmackDown Recap: KO Assaults Shane O'Mac

    SmackDown Recap: KO Assaults Shane O'Mac

    And then, Owens said he would take Shane to the top of the cell and throw him off, saying "there is no getting back up this time". Her partner, Charlotte Flair, challenges Natalya for the SmackDown Women's Championship this Sunday at Hell in a Cell .
    Gurley drives stake through Cowboys after Dak's accuracy wavers

    Gurley drives stake through Cowboys after Dak's accuracy wavers

    Over the course of the last 31:51 of game time , Los Angeles went on a 22-6 run to win a critical game on the road. Starting at its own 25-yard line, the Cowboys needed just five plays to travel the 75 yards to the end zone.