The Office of Generic Drugs (OGD) released its official approval and receipt numbers late yesterday. August saw 53 full approvals and 15 tentative approvals, leaving OGD 44 ANDA full approvals away from matching their previous FY record of 763 from FY 2017. These approvals are quite an accomplishment given the fact that the slowdown in the first few months of calendar year 2018 was so drastic.
In addition, FDA reported receiving 97 ANDAs in August for an 11 month total of 945, which means another 1000 ANDA year for receipts looks likely.
One more month to go to close out the FY. We will be back to you then to give you the year’s wrap-up.