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FDA receives record number of generic drug applications for 2017 Posted 01/09/2017

Just part way through 2017, the US Food and Drug Administration (FDA) has already received a record number of generic drug applications, surpassing the totals for both 2016 and 2015.

When drug manufacturers submit a generic drug application (known as an abbreviated new drug application or ANDA) to the FDA, they are reviewed by the Office of Generic Drugs, which is responsible for ensuring that approved generic drugs are safe, effective and of high quality. The Office publishes regular activities reports which show how many ANDAs they have received and approved.

So far for 2017, FDA has received 1,017 ANDAs. This surpasses the total for the whole of 2016 by 165 applications, and by 470 applications for 2015. Of these, the agency has issued a total of 633 approvals (and 146 tentative approvals).

It has also issued 1,292 complete response letters, which are sent when the initial review of an ANDA suggests it cannot be approved in its current form; and 110 ‘refuse-to-receive’ notices, which are issued when an ANDA is not complete enough to be reviewed (for example, if it does not show in vivo bioequivalence or if the quality of the product is not up to scratch). These figures are broadly in line with those from previous years.

However, the increase in new applications does not look likely to continue to the end of the year. According to early numbers, the Agency received just 66 ANDAs in May and 67 in June, compared to a peak of almost 200 applications in March.

The organization recently published a list of non-patented drugs without generic versions in an attempt to increase ANDAs and encourage competition in the drug market [1].

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1. GaBI Online - Generics and Biosimilars Initiative. FDA lists drugs without generics to increase competition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 1]. Available from: www.gabionline.net/Generics/General/FDA-lists-drugs-without-generics-to-increase-competition

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Source: FDA Office of Generic Drugs

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