Well, we’re just four months from the end of FY 2023 and the approval numbers still stand strong. In May, the OGD issued sixty‑three full‑approval actions and eighteen tentative‑approval actions for a total of eighty‑one approval actions. Of the sixty‑three full‑approval actions, six were first‑time generic approvals and thirteen (20.6%) were approved in the first cycle. Of the eighteen tentative‑approval actions, three (16.6%) were approved in the first cycle. There were seven imminent actions for ANDAs awaiting full approval and five for ANDAs awaiting tentative approval. What is not clear from the statistical report (here) is how these imminent actions translate into approvals after the goal date has passed. That is, how many of the imminent actions move to approval vs. Complete Response Letters (CRLs)?
Further on the action side of the house at the OGD, other notable statistics include Prior Approval Supplements (PASs), which showed the OGD approving 114, while CRLs were at the second lowest for the FY at 105 (the average thus far in FY 2023 is 129 per month). The OGD refused to receive only two ANDAs in May, and Information Requests (IRs) and Discipline Review Letters (DRLs) were about average at 322 and 195, respectively.
The OGD issued a large number (ninety‑three) of acknowledgement letters for new original applications, which likely reflects completion of the completeness and acceptability reviews for some of the 112 ANDAs received back in March. The number of ANDAs awaiting FDA action rose for the third straight month to 1,647, likely due to the higher number of ANDA submissions in March. At the same time, the number of those awaiting applicant action fell to 2,064, the lowest level of the FY thus far.
On the submission side of the business, the OGD received fifty‑eight new ANDAs in May (the monthly average thus far this FY is sixty‑four). Nine of those new ANDAs were classified by the OGD as complex products. The number of supplements submitted in May hit a high for the FY at 1,183 (the first time over 1,000 this FY) broken down into 986 Changes Being Effected supplements (CBEs) and 197 PASs. The PAS number is the highest for any given month since April 2018!
The OGD had a busy and productive month of May. Let’s hope the numbers continue to remain robust both on the action, as well as the receipt, side of the ledger. Thus far, drug shortages, the ramped up FDA enforcement activity, and the continued pressure for lower generic prices have not had an appreciable impact on small‑molecule submissions, but, if things keep going as they are, we may even find fewer submissions coming into the OGD in the future.
The rest of the monthly statistics can be found in the link above. We will be providing the unofficial June approval numbers by the end of the week!
