FDA reported 70 full approval actions and 15 tentative approval actions in September for a total of 85 approval actions for the month. The 85 approval actions fell into the second most approval actions in FY 2020 behind only April’s total of 87. The full approval action in September was also the second highest this […]
Based on our post previewing the November totals, there were some late added approvals that did not initially show up on the Agency approval databases. We reported 49 full approval actions and 8 tentative approval actions on December 3rd. With the release of the official November numbers (here), OGD issued 59 full approval actions and […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
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 […]
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 […]
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 […]
