OGD just released its March 2018 ANDA Approvals and receipts data. The results are even stronger than reported earlier (here). March officially saw 56 full approvals and 11 tentative approvals, a few more than we saw on April 3rd, as the databases became fully populated over the next few days. None of the approvals or tentative approvals were reported as first cycle approvals in the March report.
Complete Response Letters were at the lowest reported so far this FY, at 158. At the same time, however, ANDA monthly receipts were the highest for the 2018 FY so far, at 139. I believe, if I am not mistaken (and I might be), that March may be the end of the India’s fiscal year and this may explain the surge of ANDA submissions.
Looking at averages (as we are halfway through FY 2018), if things continue on the current path forward, we can anticipate 726 approvals and about 1064 ANDA submissions. I do think the approval average will climb significantly as (I am almost tired of saying it) the elemental impurity issue is resolved in many pending applications.
There was other statistical news to report as OGD updated its February numbers. There were 9 refuse-to-receive actions in March (6 for standard GDUFA II applications and 3 for priority GDUFA II applications). OGD sent out 105 acknowledgement letters, which are issued when a newly submitted application is deemed substantially complete for substantive scientific review.
There were 146 ANDA withdrawals in March (129 were for approved applications and 17 for unapproved applications (which may positively impact OGD’s total workload)). OGD approved 56 PAS supplements and none were reported as first cycle approvals.
The influx of Controlled Correspondence (CCs) remains constant, and though the first 6 months of FY 2018, OGD has received 1200 of these missives. OGD also saw the highest number of ANDA amendments in March, at 177. There are other stats to review, but nothing else much out of the ordinary. You can take a look at the full March and February reports here.
