FDA looks set to break record for generic drug applications

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So far in 2017 the US Food and Drug Administration (FDA) has approved over 630 generic drug applications, and looks set to overtake last year’s record total of 651 approvals.

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FDA has now published its fiscal year 2017 abbreviated new drug application (ANDA) approvals up until July 2017. The latest data shows that the Office of Generic Drugs has approved 633 ANDAs, with a further 145 tentative approvals. Approvals peaked in June, which saw a total of 88 applications approved.

The Office looks set to overtake last year’s record of 651 approvals, as by the same point in 2016 only 549 ANDAs had been approved.

Last year’s 835 total approvals was an FDA record for at least the eight years previous and certainly since 2012’s Generic Drug User Fee Amendments (GDUFA), which required the pharmaceutical industry to pay to cover the costs of reviewing applications [1].

The Office has received a total of 1,017 applications already in 2017, meaning over 60% of applications have been approved. Although there were fewer applications last year, 76% were approved.

The news follows a trend of increasing ANDA approvals. In 2015 for example, FDA approved only 492 ANDAs, while in 2014 there were just over 400 approvals.

Surprisingly the number of complete response letters (CRLs), which explain why a generic drug cannot be approved in its current form, have fallen compared to last year. FDA has so far issued 1,292 CRLs this year, compared to 1,365 for the same time last year. However, the number of CRLs issued so far in 2017 still exceed the totals for both 2014 and 2015.

The agency also seems to be issuing fewer refuse-to-receive notices, which are sent to manufacturers when an ANDA is not complete enough to be reviewed. It has so far issued just 110 refuse-to-receive notices, compared to 206 by the same time last year.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA reports record number of generics approvals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 25]. Available from: www.gabionline.net/Generics/General/FDA-reports-record-number-of-generics-approvals

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Source: USFDA

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