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FDA making progress with ANDA backlog Posted 06/11/2015

Despite an increase in the volume of abbreviated new drug application (ANDA) submissions, Type II API Drug Master Files (DMFs), supplements and amendments during financial year (FY)2014, the US Food and Drug Administration (FDA) has acted on more pending submissions compared to FY2013.

In the agency’s performance report on the Generic Drug User Fee Amendments (GDUFA) for FY2014 FDA outlined its accomplishments during the period of 1 October 2013 through 30 September 2014.

The performance goals outlined in the GDUFA require FDA to review 60% of generics applications submitted as ANDAs within 15 months. The agency intended to achieve this goal by FY2015, which began on 1 October 2014 and ended on 30 September 2015. FDA has set further goals for FY2016 and 2017 to review 75% of ANDAs within 15 months and 90% of ANDAs within 10 months, respectively [1].

This latest report shows that FDA has acted on 60% of the 2,866 ANDAs and 73% of the Prior Approval Supplements (PASs) that were pending as of 1 October 2012, when the GDUFA took effect. This is an increase from FY2013, where 31% and 40% of ANDAs and PASs, respectively, were acted upon.

The average total time to approval for ANDAs during FY2013 was found to be 453 days or around 15 months, so already meeting the FY2016 performance goal. Data for FY2014 was not yet available.

However, somewhat worryingly, the backlog seems to be increasing. In 2014, FDA’s Office for Generic Drugs (OGD) received a record high 1,473 ANDAs and approved only 409 of those that same year. According to Lachman Consultants, the number of submissions outpaces the number of approvals by multiples ranging from about 1.5:1 to about 3:1 each year between 2002 and 2014.

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1.   GaBI Online - Generics and Biosimilars Initiative. FDA’s faster approval of generics to benefit Indian drug makers [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 6]. Available from: www.gabionline.net/Generics/General/FDA-s-faster-approval-of-generics-to-benefit-Indian-drugmakers

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Source: US FDA

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