Since January 2018, the number of ANDA approvals has slowed dramatically. In the first three months of FY 2018 (beginning in October 2017), ANDA approvals were averaging 83 a month. The monthly average for January and February was 28.5.
We know that the slowdown in approvals was due in large part to the change in documentation requirements for elemental impurities (EI) in all applications. The good news is that we have 9 business days left in March, and OGD currently stands at 25 approvals and 2 tentative approvals for the month, according to the Recent New and Generic Drug Approvals list (here). In addition, to date in March, FDA has reported only one business day without any approvals, compared to 10 business days with no approvals in January and 2 days in February with no approvals. Both January and February also saw a flurry of approvals towards the end of the month, so it looks like March approval figures will be higher.
In previous posts, we noted that it would be at least three months until the approvals were back on track, and it appears that we may be seeing light at the end of the EI tunnel, as firms get their applications updated with the required EI information and the amendments work their way through the review and approval process.
Look for more on this issue towards the end of the month.
