Nammuang, your trying to simplify it too much. This is all legal tactics & anything Mylan can do to slow down TEVA's entry in the market. I'm sure we won't get a straight answer from ATRS's management so we're left guessing.
Mylan might have been better off not settling in the patent trial. I wouldn't be surprised to see Mylan sue the FDA once they receive the Citizen's petition response. Mylans position is the FDA is not following their own guidelines if they approve ATRS/TEVA injector.
There was no sense in getting their article once Taylor figured out how to access the petition.
"Mylan's EpiPen Defense Against Generics Focuses On Device Design
Mylan wants Teva to conduct comparative studies of its epinephrine auto-injector and to resubmit its ANDA as a 505(b)(2) NDA; citizen petition includes declaration from former FDA advisory committee member. "
I'm sure this board will see some new posters today.
I had the same problem initially.
You have to do the search from the second link (Regulations gov) & not the FDA.
If you follow the instructions above then you will find it.
So looking at the two instructions you can't see a big difference? In one you use a thumb to flip the safety clip & the other you pull the safety cap straight up. Huge difference in an emergency situation.
I saw an ER show the other day. The doctor was given an epi-injector in which the nurse & doc had never used. The doctor initially failed to administer the injection & on the second attempt she injected herself. I'm not lying.
Mylan is not dumb so are they planning to gain information with the FDA's response? Are they planning on filing an injunction? just because they have a settlement doesn't mean they won't try to block it.
That's funny, I haven't looked through the whole filing. I wouldn't be surprised they're using the wrong injector in their petition since they wouldn't have access to TEVA/ATRS epipen.
Namm, this is exactly what I've been warning posters about with the epi-pen approval. I guess this is one time I wish I had not deleted my post. TEVA/ATRS epi-pen must function exactly the same as the currently marketed epipen. They want you to be able to use the TEVA/ATRS pen while using Mylan's instructions without any questions.
Its an emergency use drug & has a higher standard in order to be A/B rated.
This petition is submitted with regard to one such specific case, and seeks to have FDA carefully apply the demanding standards it has said govern here. Publicly available (and recently confirmed) information indicates that the design and operating principles of the Teva proposed product differ significantly from those of the EpiPen® auto-injector. With that in mind, experts have analyzed the differences between the Teva proposed product and the EpiPen® auto-injector and the likely implications for safe and effective use of the proposed generic. As noted above, FDA has said the question to ask in considering whether to approve a proposed generic product such as Teva’s is whether “patients in an emergency situation can use the product safely and effectively in accordance with instructions provided for the RLD without additional physician intervention or retraining prior to use.”4 The experts’ unequivocal answer to that question is a resounding “no.”
Teva’s ANDA relies on Mylan Specialty’s EpiPen® (epinephrine injection) as the reference listed drug (RLD). Among other things, Mylan Specialty asks that the Commissioner refrain from approving the Teva ANDA unless, after conducting an appropriately rigorous review under the established standards for proposed generic emergency use auto-injectors, the agency concludes that the proposed product is the “same as” the EpiPen® auto-injector. This includes that patients, caregivers, and other relevant user groups trained in the use of the EpiPen® auto-injector who face an emergency situation are able to safely and effectively use the proposed product in accordance with the EpiPen® auto-injector instructions for use, without additional physician interaction or training. As discussed herein, Mylan Specialty believes that, because of the nature and scope of differences in design and operating principles, EpiPen®-trained users will not be able to safely and effectively use the Teva proposed product in accordance with the FDA-approved EpiPen® auto-injector instructions for use.
Found it, thanks.
FDA home page
Search- Citizens petition
Click on the first blue link - regulations gov
Then Search - Mylan Specialty also asks that FDA engage in a searching analysis