Road warning sign on a rural road.

January Hits Speed Bump for ANDA Approvals, but the ANDAs Keep Coming In

FDA updated its Activities Report of the Generic Drugs Program Monthly Performance FY2018 with its January ANDA approvals and receipt numbers.  The 25 full approvals reported for January is the lowest number since July 2014, when there were just 18 approvals.  We have blogged about the potential for a very low January approval number here, here, and here  .  FDA also tentatively approved 6 ANDAs in the January time frame.

While we think we guessed right on some of the reasons, questions remain: will the industry be able to recover in order to provide the needed information to FDA, and can OGD keep up the pace of approvals, particularly given both the tight 10-month review time and seemingly variable ability of industry to respond quickly to information requests and discipline review letters?  ANDA priorities in industry often change with changing market demands and thus industry may have to prioritize their efforts in responding to FDA’s informational requests; that delay can lead to yet another statistical trend we are also seeing, which is a sharp increase in the number of complete response letters (CRLs).

Each month this fiscal year, we have seen CRLs issued at record levels (325 [October], 240 [November], 242 [December], and 305 [January]).  The previous record for CRLs issued was in September 2016 when 193 CRLs were issued.

In addition, OGD also received 91 ANDAs in January and, with the first third of the fiscal year now in the books, we can project another 1000+ year of ANDA submissions, and, at this time, we can only project 741 full approvals based on the first four months of data.  We certainly hope that the approval numbers rebound to increase this projection for the year.  We shall keep a close eye on the numbers.