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FDA reports record number of generics approvals Posted 02/12/2016

The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) latest activity report shows an increase in approvals for generics, including 835 tentative or full approvals issued for the fiscal year (FY) 2016.

The OGD updated its Activities Report for the FY2016 on 10 November 2016, providing important information on its Generic Drug Program.

The report shows that the Office approved 835 generic drugs for FY2016 – the largest number of approvals for at least the past eight years, and certainly since the Generic Drug User Fee Amendments (GDUFA) of 2012. The GDUFA requires the pharmaceutical industry to pay fees to the OGD to help cover the costs of reviewing generic drug applications and inspecting facilities, for example.

As well as the 835 approvals, the OGD issued 1,725 Complete Response Letters (CRLs) – notices outlining deficiencies that must be addressed before an abbreviated new drug application (ANDA) can be approved. This is on average 144 per month, compared to 98 per month for FY2015, when 1,180 rejections were delivered in total. In fact, the number of CRLs is significantly higher than any year since 2012.

The activity report shows that tentative/full approvals reached their highest levels in December 2016 with 99 approvals, while CRLs peaked in September at 193. September 2016 also saw the least Refuse-to-Receive actions (when an ANDA is not complete, so FDA cannot conduct a thorough review), although the yearly total (246) is the highest since 2012.

Overall, the OGD granted on average 70 tentative or full approvals every month for FY2016, compared to 51 per month in FY2015. The figures therefore top 2015’s approval and rejection rates and mark a record number of approvals since 2012. The introduction of the GDUFA allowed FDA to hire additional staff [1] and thus achieve increases in performance. The number of approvals is predicted to increase again in the coming financial year.

1. GaBI Online - Generics and Biosimilars Initiative. FDA approves highest number of generics in 2015. [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 2]. Available from: www.gabionline.net/Generics/General/FDA-approves-highest-number-of-generics-in-2015

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Source: US FDA

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