In a blog post, The Food and Drug Administration announced that it is prepared to approve a competitor to the EpiPen just as soon as drug companies send over their applications.
From the blog post:
We stand ready to quickly review additional applications that come to us from manufacturers, especially applications for generic versions. To speed along the process, our Office of Generic Drugs prioritises and expedites our review of applications for first generics, making sure that the first applicants to make a generic are moved to the head of the queue and given priority review.
The EpiPen, which is an epinephrine auto-injector that treats people who are going through anaphylactic shock due to an allergic reaction, has been the subject of public outcry.
The drug’s price has increased by about 500% in less than a decade to $608. And while the CEO of Mylan, the company that makes the pen, has promised to provide assistance for patients in need and create a generic pen, that hasn’t satisfied consumers.
And it seems it hasn’t satisfied the FDA either.
In the post, the agency said it has already approved four epinephrine auto-injectors.
“To help development, we built a roadmap that will get these products on the market faster. In June 2013, the agency provided technical information for industry about designing and testing auto-injectors. In February, the FDA provided industry with draft guidance on how to determine if patients can effectively use the new devices,” it said.
So it looks like Mylan’s going to have a run for its money.
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