ANDA Approval Numbers for March 2016 Are In!

FDA had the second highest monthly post-GDUFA number of full ANDA approvals at 63, and with 16 tentative approvals the total for approval actions for March 2016 hits 79.

The full ANDA approval picture is looking a bit rosier with the second highest month this FY and also the second highest number of full approvals post-GDUFA. If we apply a straight line monthly average OGD appears to be heading towards a potential 691 approvals for FY 2016.   We should have the number of March 2016 receipts in a day or two and will report on those when available.  However, so far this FY, the number of ANDA receipts looks like it will eclipse the number of approvals again, but the race to balance approvals and receipts looks like it may go down to the wire as long as OGD does not get slammed in September with submissions. I know if I were a month or so away from a submission come August 2016, I might hold off on submitting the ANDA with the hope of getting a 10-month rather than a 15-month GDUFA review clock if I just wait until October 1, 2016.

We will follow this closely throughout the rest of the FY.