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Final FY 2016 Approvals and Receipts for ANDAs Just Released

OGD’s final numbers for approvals and receipts and a few other metrics for the full FY 2016 were released today.  OGD approved 51 ANDAs in September for a total of 651 for FY 2016, an average of 54.25 ANDA a month. This represents the largest number of approvals in a fiscal year in (at least )the last 8 years (and likely longer) and is the most approved under GDUFA I (previous GDUFA high was 492 which was achieved in FY 2015 and 517 in FY 2012 prior to GDUFA).  That’s the good news! The bad news is that OGD received a total of 853 ANDA (71/ANDAs/mo) in FY 2016 which is 202 more ANDA than it approved.  It is true there were also 184 tentative approvals in FY 2016 but that still leaves OGD a little short on the balance sheet.

Surprisingly, September saw the submission of 60 ANDAs as we predicted (with the new review metric of 90% of the ANDAs with first action in 10 months to kick in at the start of FT 2017) that firms might wait until after October 1 to submit their application to take advantage of the potential 5-month shorter review clock.  In addition to the 5-month advantage, we thought that (with an almost $6000 reduction in ANDA fees for FY 2017) that September would be a lean month for submissions.  And while the 60 ANDAs submitted in September is below the monthly average of 71 submitted for FY 2016, we still may not yet have seen the impact of the lower fees and 5-month review advantage until the first few months of FY 2017.  That will be an interesting one to watch especially if quite a few ANDAs were held back from submission in the last quarter of FY 2016 to take advantage of the new metrics and fees.

In September 2016, OGD issued the highest number of Complete Response Letters (CRLs) in any month of FY 2016 at 193 (previous high was 190 in April of 2016). For FY 2016, OGD issued a total of 1725 CRLs which is significantly higher (by almost 500 CRLs) than any of the previous GDUFA I years.

So what do we think industry will look for in FY 2017?  My guess is that their expectations would be a continued increase in the number of approvals per month to approach a number that maybe closer to 75-80/month.  They will certainly expect to attain more approvals than OGD gets ANDA receipts,  improved communications, better information on compliance status and resolution, and more clarity on guidance documents and OGD policy.  Those are my best guesses. What are yours?