With just eleven of the twenty-two working days left in July for the OGD to report approval actions, the number of full approval actions stands at twenty-nine and tentative approval actions sit at eight, for a total of thirty-seven so far this month. These numbers are derived from the FDA’s All Approvals page here.
OGD released its official approval and receipt numbers on Wednesday afternoon and, as was predicted (almost) in our previous blog (here), it was somewhat disappointing. We missed the approval actions by one. OGD actually issued 45 approval actions (we found only 44), and they issued 17 (as predicted) tentative approval actions for a total of 62 approval actions for June 2019.
We reported here that June may be a gloomy month for approval actions. A few days ahead of the release of the official OGD numbers, it looks like we were on target. As reported through this morning on FDA All Approvals List (here), OGD had issued 44 full approval actions and 17 tentative approval for a total of 61 approval actions in June.
This time of year, in southern California, the marine layer (low fog and clouds) hangs over the first few miles of the coast. We call it June gloom. Everyone either goes inland to see the sun or just waits it out until the Fourth of July weekend when the weather usually turns to the glorious,
The Office of Generic Drugs released its first set of metrics this morning for May which shows (as previously reported here), 83 full approval actions and 12 tentative approval actions (1 more in each category than estimated in the post cited above), for a total of 95 approval actions. This is the first time this FY that the total has fallen below 100 approval actions in a single month.
In our post from June 10, 2019 (here), we commented on an apparent revision in the number of approved ANDAs from the month of April (a change from 98 to 93). While scratching our heads about the apparent discrepancy, the FDA’s Kristofer Baumgartner, M.A., Director, Division of Public Education and Outreach,
For the first time this fiscal year (FY), it looks like the OGD will have taken fewer than 100 total final and tentative “approval actions” in a month. While we await the official OGD figures (which should be reported sometime next week), so far, for May, as gleaned from the FDA “All Approvals” page (here),
On May 20, 2019, the Office of Generic Drugs approved 13 ANDAs for Solifenacin, a generic version of the Brand Vesicare. The drug is used for treatment of overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence.
The approvals came after pediatric exclusivity was granted which “effectively extended” the patent by 180-days on the innovator product (not actually a patent extension,
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.