FDA reduces generic ANDA backlog

The latest quarterly update from the Office of Generic Drugs (OGD) shows that the US Food and Drug Administration (FDA) is getting through the backlog of abbreviated new drug applications (ANDAs).

Last year, the agency approved more than 700 generic drugs and the number of filed ANDAs with no communications from FDA fell from 581 to 351 ANDAs as of 1 January 2016 versus 1 January 2017.

According to the published dashboard, the number of ANDAs currently with FDA is 2,358 (compared to 2,962 last year), while the number of ANDAs with industry for action is 1,847 (compared to 1,143 last year). So it appears that the amount of ANDA work is increasing for industry whilst apparently decreasing for the FDA.

Click here to view the latest Generic Drug Review Dashboard.