FDA approves Teva's generic EpiPen after yearslong delay
S E E D E D C O N T E N T
FDA approves Teva's generic EpiPen after yearslong delay
By Meg Tirrell, CNBC (msn.com), August 16 2018
U.S. regulators cleared the first generic competitor to Mylan's EpiPen, after a yearslong delay that many said contributed to the emergency allergy drug's rapid rise in price.
Teva Pharmaceuticals received Food and Drug Administration approval for generic versions of both the EpiPen and EpiPen Jr, the agency said in a statement Tuesday.
The products are the first competitors cleared by the FDA that are direct generic copies of the EpiPen and could be substituted for the brand-name product by a pharmacist. Other versions of epinephrine auto-injectors, such as the Adrenaclick and Auvi-Q, are on the market, but aren't considered EpiPen generics.
"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," FDA Commissioner Scott Gottlieb said in the statement.
Mylan introduced its own authorized generic form of the EpiPen in late 2016, after an uproar about the branded version's price, which rose more than 400 percent over a decade. The authorized generic, identical to the original except without the brand name, cost half the price: $300 for a two-pack.
Teva could seek to compete by pricing its generic version even lower; typically, it takes multiple generic copies of a medicine entering the market to see prices collapse substantially.
The Israeli company's application for a generic EpiPen was rejected by the FDA in early 2016, just before the rising price of Mylan's product exploded into a major news story heading into back-to-school season, when parents often stock up for kids with allergies.
Though the key ingredient in the EpiPen, epinephrine, has been available for decades and is no longer covered by a patent, generic copies of the device have struggled to reach the market because the product is technically a drug-device combination, and the delivery device proved hard for generic competitors to copy to a degree that would satisfy regulators.
The FDA issued guidance in November 2017 to try to make it easier for generic copies of complex medicines like the EpiPen to reach the market, saying some design differences may be approved as substitutable products, as long as those differences don't affect patients' ability to use the product the way it's intended.
The FDA said Teva's generic products are expected to produce the same clinical effect and have the same safety profile as the EpiPen and EpiPen Jr. There are small differences in design, the regulator said, but they won't affect safety or efficacy.
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It's about time. This approval could surely have been provided long ago, saving MANY people a lot of money.
Can you remember when the owner of the original epi-pen was chastised for overpricing and making herself rich on the backs of so many people who needed this device, to possibly save their lives and the lives of their children. Dr. Jonas Salk she was NOT.
For those who may not know, Dr. Jonas Salk, who developed the serum to prevent poliomyelitis (FDR was a victim of it), refused to patent the serum and virtually GAVE it to the world, shunning the fortune he could have earned. That is what a true humanitarian is.
This is great news. Teva stock has taken a beating in the last several months. Hopefully this will help that situation.
As you can see, this is the news you hoped for:
https://www.jpost.com/HEALTH-SCIENCE/Teva-jumps-on-FDA-approval-for-generic-EpiPen-565205?utm_source=newsletter&utm_campaign=19-2-2018&utm_content=teva-jumps-on-fda-approval-for-generic-epipen-565205
Dear Friend Buzz: At long last some progress.
Next should be flexpen generics for long and short term insulin injections.
Insulin ins't even a drug.
It is a naturally occuring hormone.
In present form, it is a recombinant DNA injectable fluid.
It has been around to treat diabetes mellitus, types I, II and gestational since before there were generics.
There is an epidemic of diabetes, mostly type II around the world.
Ninety day supplies of short and long term insulins can cost into the thousands of dollars.
People die prematurely, and have the quality of their life and health reduced when they cannot afford to pay that freight.
If anyone other than a drug manufacturer caused premature death and injury on the scale of pharmaceutical corporations they would long ago have faced the full weight of the law upon them.
Time for the government here in the USA to govern.
Enoch.
I've had Type 2 Diabetes for years, but keep it under control with Metformin pills - never serious enough to require insulin.
Me too, recently started on Trulicity, though I'm a bit nervous about it and don't much care for the side effects.
I'm glad they approved the generic form of the epipen. Healhcare costs are breaking families her in the U.S. and profiteering hurts them more.
I’ve had it for some years too. Had been using only diet and excercise only but now it’s advanced despite my efforts to where ten days ago I began using the smallest dose of metformin 2x a day.
Dear Friend Heartland America: Your experience dovetails that of many if not most other type II diabetics.
Over time, people wear out.
Diet, exercise, stress management, good sleep and other health habits are all part of the mix.
You are planning out everything well.
Your plan execution is excellent.
Bravo.
Peace, Abundant Blessings and the Good Health to Enjoy Them.
Enoch.
Dear Friend Spikegary: Keep me in the loop on how the Trulicity is working out for you please.
E.
Thank you!
The drug company lobbies are very, very powerful.
Dear Friend Krishna: Correct.
Far too powerful for the good of the people.
Isn't that tragic?
E.
I won't get excited about this news until the cost is revealed.
Many people near the border cross it to buy their medications in Canada, where generics are readily available, and they always cost a lot less that brand medications. I would not be surprised if TEVA sold epipens for half or less the price of the present brands.
You are likely right as that has been my experience. When I look at an Rx and it says TEVA on it I know I’m getting a good product.