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FDA approves more generics in 2018 than any other year Posted 30/11/2018

The US Food and Drug Administration (FDA) approved 971 generics in 2018, more than in any previous year, according to the Activities Report of the Generic Drug Program (FY 2018).

The 971 total includes 781 final approvals and 190 tentative approvals compared to 937 total in FY 2017, which was the highest number of approvals until now.

The agency also set a record for the number of Complete Responses or written letters to applicants identifying deficiencies that applicants needed to resolve before approval of an abbreviated new drug application (ANDA). For FY 2018, FDA issued a whopping 2,648 Complete Responses compared to 1,603 in FY 2017 and 1,725 in FY 2016, although some of this increase have been attributed to the switch from Generic Drug User Fee Amendments (GDUFA) I to GDUFA II.

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. In FY 2018, it issued just 127 refuse-to-receive notices, compared to 142 in FY 2017 and 246 in FY 2016.

The increase in approvals fits in with FDA’s strategy to increase competition in the market for prescription drugs through the approval of lower-cost generics. FDA Commissioner Scott Gottlieb said ‘when I started as FDA commissioner, I made clear that one of my top priorities would be ensuring the agency does all it can to help ensure American patients have access to affordable, quality medicines that meet their needs. To accomplish this, we have taken many important actions to encourage the timely development and approval of lower-cost generic drugs and are beginning to see results’.

The US Government has not hidden its strategy to reduce drug prices by increasing competition. As part of this strategy, FDA launched a Drug Competition Action Plan in June 2017, which included publishing a list of drugs without generics [1]. This list was updated and reorganized into two parts in December 2017 [2] and updated again in June 2018. FDA ‘maintains this list to improve transparency and encourage the development and submission of ANDAs in markets with little competition’. The updated list now contains 11 drugs that previously did not have an approved generic despite the expiry of the reference product’s patents and exclusivity. The list will be updated every six months.

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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 2018 Nov 30]. Available from: www.gabionline.net/Generics/General/FDA-lists-drugs-without-generics-to-increase-competition
2. GaBI Online - Generics and Biosimilars Initiative. FDA updates its list of drugs without generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Guidelines/FDA-updates-its-list-of-drugs-without-generics

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Source: US FDA

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