The Office of Generic Drugs (OGD) received 55 original ANDAs in April 2016, the third highest number of receipts in the 8 months of FY 2016. The two higher months were December 2015 (180) and March 2016 (114). OGD has received a total of 527 ANDA or an average of just a little over 75 (75.3) ANDAs/month so far this FY. If this rate continues, OGD is likely to receive a total of approximately 903 ANDAs for the current FY.
If we look at the total number of projected approvals (684) versus the number of receipts (903) for this FY, it appears that the gap between approvals and receipts is narrowing. However, OGD is still receiving more ANDAs than it is approving, meaning the backlog continues to grow. Even if we add the number of tentative approvals (TAs) of 109 to the full approvals, the number of receipts still outpaces approval actions. And remember – TAs don’t always move directly to approval if there are changes that the sponsor needs to make post-issuance of the TA.
Does the phrase “the hurrieder I go the behinder I get” start to sound familiar?