Are April Showers Dampening April ANDA Approvals?

Here we are at April 11^th and through the 9^th, the first 6 business days of April, there have been 5 ANDA full approvals reported so far on the FDA’s Recent and New and Generic Approvals list (here  as of the morning of April 11^th at 730AM). April 2 and 3 saw no approvals reported and the 4^th, 5^th and 9^th saw one each with April 6^th reporting 2 ANDA approvals.  There have been no tentative approvals posted to date.  This represent the worst start of any 2018 FY month since the January slow down due to the elemental impurities issue.  We must acknowledge that some approvals take a while to appear on the list cited above so the full picture may not be available now.

Perhaps OGD’s effort at towards the end of March left little for the beginning of April.  Perhaps we will see a great improvement as the month moves along.  I am hearing from some industry sources that they anticipate larger number of approvals in June but I cannot nail down the basis for those predictions.  Let’s hope they are right.

Now at least we must assume that the early showers (and snow in some parts of the country) will have approvals sprouting towards the latter part of the month.