We previously noted that April would likely be a good month for OGD approvals, and it was! The OGD approved 85 ANDAs, of which 41were first-time generics; however, only 10 (11.7%) were first-cycle approvals. This low percentage of first-cycle approvals is likely because of the large number of single-entity and combination dapagliflozin products that were approved after patent expiration. However, the projected number of ANDA approvals for the full fiscal year (FY) rose to 723 at the current rate. Of the 19 tentative approvals (TAs), only 1 (5%) was approved in the first cycle. This is also likely due to the large number of TAs for the products cited above based on 180-day patent exclusivity issues.
On another good note, there were no refuse-to-receive letters issued to original ANDAs in April. The OGD acknowledged 53 new ANDAs during the month and issued only 84 Complete Response Letters (CRLs).
The OGD approved 124 prior approval supplements (the second lowest number in any month this FY). The OGD also issued 387 information requests, 199 for original ANDAs and 188 for supplemental applications. In addition, the OGD issued 101 discipline review letters, the lowest number thus far in a month this FY, likely due to the significant work that was required to get out the large number of approvals for the large batch of products noted above.
There were 12 reclassifications of a facility-based major amendment CRLs granted, which is the highest number granted in a single month so far this FY.
As to the OGD’s application workload, the number of pending ANDAs awaiting FDA action jumped back up to 1,300 after being considerably below the 1,300-level for the past three months. ANDAs awaiting applicant action fell below the 1,800-level for the first time this FY and landed at 1,783, broken down as 561 tentative-approval actions outstanding and 1,222 CRLs not yet answered.
On the receipt side of the house, the OGD received 49 new ANDAs and, projecting the full FY receipts, the OGD is expected to receive 613 new ANDA applications. The big question is, will the total fall below the 600-level received last year?
