OGD Reports Increase in Generics Approvals, CRLs in 2016

The Office of Generic Drugs topped last year’s approval and rejection rates, issuing 835 tentative or full approvals and 1,725 complete response letters in fiscal 2016.

These figures mark a record in approvals since the generics user fees were first enacted in 2012, Bob Pollock, a former deputy director for OGD, said.

On average, the OGD granted about 70 tentative or full approvals each month, compared with 51 per month in fiscal 2015. It also reported an average of about 144 CRLs per month, compared to roughly 98 per month last year, when it delivered 1,180 rejections in total.

According to OGD’s latest activity report, tentative and full approvals peaked in December 2016, with 99 approvals. CRLs, on the other hand, reached a record in September, with 193 rejections.