The FDA announced today (here) the first approval of a generic equivalent to Epi-Pen, the combination product used to treat severe allergic reactions. The FDA’s announcement acknowledges that approval of “complex” generics, like some combination (drug/device) products, can be very challenging.
The FDA has always said that for most complex drug device products, the product needs to perform the same as the reference listed drug it copies. As one can imagine, for a drug used to treat a life-threatening allergic reaction, there is no time to read and learn new directions for use. Thus, the product approved must be able to be used without patient retraining.
Well, this did take a long time, about ten years and four months, based on the approximate timing derived from the ANDA number (likely submitted around April 2008). There has been quite a lot of speculation as to whether a generic version of Epi-Pen would ever be approved. Today, the FDA answered that question.
In describing the road to approval, FDA Commissioner Dr. Scott Gottlieb cited the process “outlined in our (FDA’s) Drug Competition Action Plan, announced last year. We’re especially committed to the development of generic copies of complex products.” This one ranks up there with some of the notable and lengthy complex generic approvals like enoxaparin, glatiramer, and clonidine transdermal patches. Read more on how the commissioner described the product and process at the link cited above.
