OGD topped the initial projection of both approvals and tentative approvals from my May 2 post (here) hitting 66 full approvals (predicted 62), and 16 tentative approvals (at the time there were only 9) for a total of 82 approval actions. This is good news for the generic industry, as it appears that each month OGD is moving back to its “new normal”. The beginning of May is also looking good from an early approvals standpoint; as of this posting, I could find 15 full approvals and 2 tentative approvals in the first 4 business days of May.
ANDA receipts were brisk again in April with 84 submissions, and FDA reported issuing 142 complete response letters, the lowest so far this FY. It is funny how when the CRL go down, the number of approvals go up! Check out the updated figures here.
