Update on Valsartan “Priority” Review

The FDA’s posting of the approval for the “priority” review ANDA for Valsartan mentioned yesterday (here) occurred today.  The ANDA number was listed as 205536.  It is interesting to note that the ANDA number corresponds to an application that was submitted around the middle of 2013.  That is almost six years!  It is interesting to note the words “priority” and “expedited” in the context of the review of an application that is as old as that.

Perhaps the firm was no longer seeking approval because of the large number of other approved ANDAs for this drug, and, since the ANDA had not yet been withdrawn, the FDA asked the firm to continue processing the application, or it could just be one of the early GDUFA submissions that got lost in the initial backlog shuffle.

Nonetheless, the ANDA found new legs and answered a call to help with a drug shortage.