Innovators often discontinue products when they are no longer profitable.  And, as we all know, to file an ANDA as a duplicate of an approved NDA product, the ANDA applicant must refer to a Reference Listed Drug (RLD) approved for safety and efficacy under section 505(c) of the Act.  There are times when an ANDA may be a reference standard—we all know that—but how can an ANDA be a RLD also?

The FDA published a list titled Reference Listed Drugs by ANDA Reference Standard (here).  “The purpose of this list is to assist applicants submitting an ANDA to seek approval of a generic drug in identifying an RLD when an ANDA RS has been selected.”  But, as you may notice, there are a number of ANDAs listed as RLDs (with an “A” designation) that appear on that list.

Remember the relatively recently coined (as of two years ago) term PANDA (Pre‑Hatch‑Waxman ANDA)?  Well, this is how an ANDA can be an RLD.  It stems from these products, which were approved prior to Hatch‑Waxman’s implementation in 1984.  Please see our prior post here for a full discussion of PANDAs as well as a link to the Federal Register Notice that described this historical anomaly in more detail.  (As a note, the FDA has still not formally decided how it is going to address all of the issues surrounding the PANDAs, but that is not the real reason for this post.)

As we get back to the updated Reference Listed Drugs by ANDA Reference Standard published just a few days ago and cited above, there are some 264 products on the list, including 236 NDAs that the FDA has designated as RLDs, and 28 ANDAs (that are PANDAs) that have been designated as RLDs.  The list is updated monthly but it occurred to me, upon reviewing it, that there are still unanswered questions for PANDAs that must be addressed by the FDA, and it appears that the Agency is still struggling with just how to reconcile the complex PANDA issues.  Maybe silence is the best medicine as no one has complained, but there will eventually come a day of reckoning!  We will keep an eye out for you and, if you see a PANDA or reference one in an ANDA, don’t feel bamboozled (pun intended).