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 […]
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, came to the rescue […]
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 […]
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 […]
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, as […]
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 […]
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 […]
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 […]
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 […]
