As of August 15th, the OGD has issued 28 full approval actions and 7 tentative approval (TA) actions. When the Generic Drugs Program Monthly and Quarterly Activities Report is issued, the total number of TA actions will be decreased by 2 based on the fact that two are for second TA action letters issued thus far in August for the same product.
With 35 total approval actions through the first half of the month, this could be one of the slowest months for approval actions this fiscal year. The above figures represent posting through the 15th of August. Granted, a few more approvals might show up over the next few days as OGD postings are sometimes delayed by a few days but, as of now, the month started out strong with at least four days yielding more than 5 approvals (one with 7 approval actions and 4 TA actions); however, since August 11th, the number of approvals has been pretty slim.
Perhaps we’ll see an influx of approval actions towards the later part of the month? We’ll just have to wait and see.
