Today, FDA posted the official ANDA approval actions and receipts for April 2019. While the All Approval list reported 93 full ANDA approval actions and 15 tentative approval actions for ANDAs, when we wrote our first blog estimating the approval actions for April on May 3rd (here) , the official FDA numbers for April reported for approval actions was 98 and tentative approval actions was 18,
Browsing the daily articles is always fun, whether it is trolling for stories of interest or for something that just makes you want to start banging your head against your keyboard. Today I read an article (here) from the Times of India’s business section. It outlined the number of approvals from Indian-based companies,
So far this FY, total approval actions (note that we are no longer saying approvals) have topped 100 each and every month, from a high of 132 (note that that figure was originally reported as 128, before FDA implemented its revised approval action counting reporting method (see previous post here). While the official April numbers are not out yet,
With four reporting days remaining in April, the Office of Generic Drugs has issued full approval actions on sixty-nine ANDAs and tentative approval actions on thirteen ANDAs for a total of eighty-two approval actions. We remind our readers of the potential difference from actual individual ANDA approvals or actual individual ANDA tentative approvals based on a new footnote found at the bottom of the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance first appearing sometime in April 2019 (here) and further discussed in our blog post of April 16th (here).
As I was reviewing the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here) as I do a few times a month, I came across a new footnote to the report. It reads:
++++ = FY19 Approval and Tentative Approval counts were updated in April 2019 to better reflect program output by capturing all approval actions on original applications,
March 2019 actually saw 89 full approvals and 17 tentative approvals for 106 approval actions (our predictions were off by one). This is another good month for ANDA approvals, but it is also a month that saw the largest number of ANDA submission for FY 2019 at 118. We believe this corresponds to the end of the fiscal year for India,
The OGD had what appears to be another good month, fully approving eighty-eight ANDAs and tentatively approving seventeen ANDAs for a total of 105 approval actions. While a few stragglers may still be lurking and not yet listed on the FDA All Approvals page (here), it looks like a good and productive month for the OGD.
Well, for the first time, our initial estimates of approval actions for a month was higher than the reported official figures, but are they really? Don’t know exactly how that happened because our estimates are usually below the totals. Anyway, the official figures posted today (here) were eight-two full approvals and seventeen tentative approvals.
So far, for February 2019, it looks like OGD fully approved 83 ANDAs and tentatively approved 23 ANDAs. Of course, the final official numbers won’t be in for about another week or so, but it looks like another month in the 100’s (OGD total of 100 or greater approval actions was missed only one month so far this FY).
OGD just released its official January approval figures and we nailed it in our previous post here, where it was reported that OGD would have 102 approval actions in January, despite the shutdown. Well, we actually hit the nail on the head, as OGD did indeed break the 100-approval action mark by fully approving eighty-one ANDAs and tentatively approving twenty-one ANDAs.
With 5 working days left in January, and despite the turmoil this month has seen, we stand at 58 Full approvals and 17 Tentative approvals reported on the FDA All Approvals page (here) through January 24, 2019.
Looking at the first quarter approvals (October thru December), there were a total of 278 full approvals which,
OGD fully approved 69 original ANDAs and tentatively approved 31 for a total approval action of 100. This is actually 18 more than we were able to spot on the FDA all approvals actions in our January 3rd post (here). Not bad, considering the short month with vacations and the Federal government shutdown that started December 22 so actually represents a better result than what we anticipated.
With the holidays, vacations and the partial government shutdown, OGD did not do too badly, with total approval actions of 82 and still a workday to go (and there are always those pesky approvals or tentative approvals that show up after the final bell). This looks to be one of those “down months” that Cook talked about (I might add there have not been many of them recently),
To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year. The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as we follow the ever-changing landscape of FDA regulatory science,
It appears that 128 is the magic number for the OGD as last month they also had 128 approval actions. November numbers saw a different split between full approvals and tentative approvals (99 and 29, respectively). The 128 total approval actions obviously ties last month record number of approval actions for a single month.