With six (6) reporting days left in the month, the FDA’s All Approvals List (here) has identified 43 full ANDA approval actions and 10 tentative approval actions. While this represents a bit slower pace for approval actions, there is still time to meet FY 2020 monthly averages by the end of the month. We want […]
As of August 5, 2020, the FDA had posted 69 full approval actions and 9 tentative approval actions for ANDAs for July 2020. The total of 78 approval actions for the month of July fall short of the 87 Approval actions in June but appears to be consistent with the last four month’s totals. Some […]
Well, there were some hidden tentative approval actions that must have been posted fairly late after June was over as the OGD official numbers released for June show OGD had 14 Tentative Approval (TA) actions (we reported just 5 in our post on July 6 [here]). (However, when looking at the FDA all approvals list […]
Well, June was apparently another good month for the OGD FDA work-from-home teams as the unofficial counts of the numbers show they managed 74 full approval actions and 5 tentative approval actions. The 74 full approval actions represented the highest total in a single month thus far in FY 2020, beating the next highest of […]
OGD approval numbers have surged through June 15th as OGD has already issued 44 full approval actions and 4 tentative approval actions. 14 of those full approvals came on the 15th and 16th of June. Six of those approval actions were for Deferasirox Tablets, 90 mg, a generic of Jadenu. It appears that the block […]
The Office of Generic Drugs (OGD) updated its April stats and notes 4 refuse-to-receive (RTR) actions (3 standard ANDAs and 1 priority application) which is in line with what we have seen so far this entire FY (months average for 7 months is 3.6 RTRs/month). OGD also acknowledged 65 new ANDAs in April. Of the […]
Another month for FDA reviewers mostly on stay-at-home work due to the COVID-19 pandemic, and with the states beginning to open slowly, the Office of Generic Drugs (OGD) is chugging right along regarding its approval pace. OGD’s unofficial full approval actions for May of 63 is tied for second place among FY 2020 months thus […]
Through April 19 (and one action for the 20th) reporting on the FDA all Approvals list (here) tallies 37 full approval actions and 16 tentative approval actions for a total of 53 approval actions. The month started out very strong and, if the rate of approvals continues through the end of the month, OGD might […]
Remote work by the generic drug program staff did not seem to negatively impact the approval actions for ANDAs in March. The entire generic drug program staff was likely feeling the same (or even higher) anxiety that we are all feeling, with the stay at home orders in place. Speaking from experience, the coordination for […]
Because we know that information regarding approval actions of original ANDAs is critical to the industry, we track them as closely as we possibly can in order to give the readers the latest information. The full approval and tentative approval actions are the lifeblood of the industry. February 2020 continues on the lower end, and […]
