Well, the first quarter of approval actions for original ANDA and receipts are in the books. We reported late last week that OGD fully approved 78 ANDAs and tentatively approved 19 ANDAs – well, we were as close as we ever have been, estimating using numbers derived from various FDA statistical reports… and the official numbers for November 2018 are – 78 full ANDA approvals and 20 ANDA tentative approvals for a total of 98 approval actions. We only missed by one!
So let’s take a guess at what the first quarter of FY 2018 might look like if we straight line the numbers so far! Based on the numbers to date, OGD is averaging 83 full approvals a month. If that pace keeps up, then OGD could approve 996 ANDA by the end of the FY. This would clearly be a significant increase over the previous record of 763 reached last FY.
That is the good news, now let’s look at the ANDA receipts. So far, OGD has been averaging 82 receipts a month in the first quarter of FY 2018 (with 131 coming in in December- the end of the year rush!) and this would translate to about 984 ANDA for the full fiscal year if the rate of receipts continues at this pace. Hey, wait a minute – that means that OGD would be about even for approvals vs receipts of original ANDA for the first time since the beginning of the GDUFA era, thus OGD might even have an absolute plus (albeit small) for approvals vs receipts! That’s good news too!
The only other metric OGD has reported for its December numbers is for complete response letters. That number came in at 243 for December vs 240 and 325 for the previous two months.
We previously predicted that, when the number of complete response goes down, then the number of approvals go up. This might be fiction, or it just may be one of those metrics that doesn’t really predict anything.