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Regulatory Focus™ > News Articles > FDA Continues to Reduce Generic Drug Backlog

FDA Continues to Reduce Generic Drug Backlog

Posted 22 February 2017 | By Zachary Brennan 

The US Food and Drug Administration (FDA) on Wednesday revealed that it approved more than 700 abbreviated new drug applications (ANDAs) for generic drugs in 2016, though the number of ANDAs pending an industry response also rose by more than 700.

According to the most recent generic drug review dashboard, the number of ANDAs filed with no communications yet from FDA also fell from 581 ANDAs as of 1 January 2016 to 351 ANDAs as of 1 January 2017.


The dashboard shows that the burden of ANDA work is also increasing for industry while decreasing for FDA. The number of ANDAs currently with FDA is at 2,358 (compared to 2,962 from last year’s dashboard), while the number of ANDAs awaiting industry action is at 1,847 (compared to 1,143 last year). Seven first generics have also been approved so far in 2017.

Here’s a look at the ANDA approval numbers from 2016:



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