The yin and yang between approvals and receipts of original ANDAs is always a balance that the Office of Generic Drugs (OGD) must deal with, and OGD only has control of one of these metrics. The number of original ANDAs submitted in February was the second highest for FY 2016 with a total of 62 received. This pales in comparison with the December figure of 180, but is still indicative of the fact that OGD can expect more applications this year than last.
So far, in this FY, OGD has received and average of about 71.4 ANDAs/month. A straight line projection of that average would yield about 857 ANDAs this FY, or about 248 more than the 509 ANDAs OGD received in FY 2015. The 857 (while lower than the receipts in over 5 years) is still above the anticipated number of 750 ANDAs that FDA estimated per year for GUDFA years 1-5.
The low number of receipts in FY 2015 (509) gave the Agency some breathing room to deal with the huge number of receipts over the first 3 years of the GDUFA program. Can OGD continue to absorb numbers significantly about their estimates and continue to meet GDUFA goals? I am certain that they can and must because they have to answer not only to industry, but also to Congress. The real question is, what resources will be expended in meeting the GDUFA goals and will the “backlog” and years 1 and 2 GDUFA submissions suffer?
Only time will tell, but OGD looks to be on another year of higher submissions and, even though the big submission month was in December 2015 (180 ANDAs received), with the potential for GDUFA rate increases in October, will we see another spike in the September 2016 submissions? Hold onto your hats as the wild ride continues!