Much like all we do at tax time, we look for anything that might lower our taxes. We look for deductions, charitable gifts, donations, business expenses and do a lot of hope and praying. Well, FDA had a corollary situation when they were looking at how to count and where to place ANDAs in the submission queue, which were submitted during the government shut down. And now, I am glad to say, the FDA figured it all out; however, firms likely won’t know for sure where their ANDAs stand relative to the “submission” or receipt date until they receive their filing letter from OGD.
At least we know the numbers (reported here), and while there were some much larger predictions (even one made by me), it looks like a typical receipt profile for the months of December and January where OGD reports receiving 107 and 74 ANDAs, respectively. December, as expected, was the biggest month so far this FY and represents the only triple digit receipt month so far. We know that March is likely to be big as well since that is the end of India’s FY.
Taking the first quarter total receipts of 318 and projecting that forward for the full FY we can, at this point, expect the FY 2019 total to be about 960, which will be the lowest number of ANDA submission since FY 2016 when 852 were received. Remember that we are predicting a record-breaking number of approvals for FY 2019 to hit at about 1067 based on the current rate of approvals.
So I wish you good luck with your taxes and good luck when you receive your receipt letter. It will be interesting to see if everyone is happy with either!