OGD reported 69 full approval actions, which we hit on the head, (three of the full approvals were for first time generic approvals) and 13 tentative approval actions (we reported only 9, as that was all that was found on the FDA’s All Approvals site at the time) for a total of 82 approval actions for July 2020. The posting of tentative approval actions appears to lag days or even weeks behind the posting of full approval actions at times.
Other July official metrics reported include, 160 complete response letters, which is a jump from June’s 124, and more in line with the monthly average. OGD received 68 new ANDAs in July which is the fourth highest month for receipts in FY 2020. The full battery of July metrics will likely be posted sometime in mid-September.
Looking at ANDA approval and receipt projections for the full year, if the rates remains the same for the last two months, expect to see about 730 approvals (about 200 fewer than FY 2019) and 877 new ANDAS received (909 in FY 2019) for FY 2020. Of course, if there is a rush for FY end submissions the receipt number could be higher. With ANDA user fees for ANDAs increasing by about $20,000 beginning October 1, 2021, firms may push to submit applications before that date. We just will have to wait to see. If there are a rush of September receipts, it will be interesting to see how many refuse-to-receive (RTR) actions are reported for October and November 2020 when the new applications received in September have their completeness and acceptability reviews.
The June metrics update looks like this. OGD only refused-to-receive one (1) ANDA which was for a standard review application and this ties a low so far for this FY which occurred in October 2019. The OGD acknowledged 73 new ANDAs and total ANDA withdraws hit a low for FY 2020 at 14 (8 approved and 6 unapproved ANDAs).
Of the 73 full approval actions in June, 13 (or 17.8%) were first cycle approvals and of the 14 tentative approval actions, 1 (or 7%) was a first cycle TA. Information requests were up above 400 (413) for the third time this FY and discipline review letters (DRL) soared to 335, over 100 more than in any other month this FY. This may show the efforts that OGD is placing on getting deficiencies to sponsors early in the review process, so they have sufficient time to respond to deficiencies early enough to include the review of the applicant’s response to the DRL in the open review cycle.
Amendments to ANDAs were reported at 282, which was tied for April for the highest number of amendments submitted so far this FY. Changes being effected (CBE) supplements and prior approval supplements both hit highs for the year at 951, and 113 respectively.
The full figures reported in this post can be found in the Generic Drugs Program Activities Report – Monthly Performance Fiscal Year 2020 (here).