The Office of Generic Drugs (OGD) filled in the remaining data boxes in the March Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance (here) and there are some very interesting numbers to point out.
Of the 9 refuse-to-receive (RTR) actions OGD issued last month, 6 were for GDUFA II priority applications, 1 for a standard GDUFA II application and one for a GDUFA I application (which has been around for a while since we are now 7 months into the first year of GDUFA II.
OGD acknowledged 86 ANDA in March, and reported no RTR actions on prior approval supplements (PAS). There were 43 ANDA withdrawals during the month (23 approved ANDAs and 20 unapproved ANDAs).
Of the 57 full approvals in March, 7 were first cycle approvals and of the 11 tentative approvals (TAs) previously reported OGD indicates that 3 were first cycle TAs. First cycle approvals are of particular interest as OGD hope to raise the percentages of first cycle approvals to help move ANDAs through the system faster and increase the efficiency of the process. The issuance of information requests (IR) (429) and discipline review (DR) letters (224) soared in March, both reaching the highest number in FY 2018 so far, with DR letters more than doubling any previous month this FY. Getting information to applicants during the review process so they can address them prior to getting a complete response letter also helps the applicants to gains first cycle approvals. But does the industry have the bandwidth to respond in a timely manner to all these requests for information?
Industry has been busy as well and has submitted the largest number of amendments (191 (84 major amendments, 105 minor amendments and 2 unsolicited amendments)) so far this FY. As far as supplements go, Industry submitted the fewest number of changes being affected (CBE) supplements of the year at 361, but the most PAS supplements in a month at 179.
The rest of the statistics report were within usual range. We will continue to closely track ANDA activity as we know it is of special interest to the industry.