FDA, New Products

FDA sets record for number of generic drug approvals again

The FDA has approved and tentatively approved more generic drugs in FY 2018 than any other year prior, the agency announced Thursday.

The 971 total includes 781 final approvals and 190 tentative approvals, which compares with 937 total in FY 2017, which was the highest number of approvals since 2016, which at the time set the previous record.

Scott Gottlieb

“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,” FDA Commissioner Scott Gottlieb said in a statement.

Of the approvals in FY 2018, the FDA said about 12% were for complex generics, like EpiPens, while 95 first generics were approved in the fiscal year.

In addition, three new approvals received a Competitive Generic Therapy (CGT) designation this year, which is meant to expedite the development and review of generic versions of products that lack competition. The first generic to receive the designation came for several strengths of potassium chloride oral solution, which is indicated for the treatment and prevention of hypokalemia (low potassium blood levels) in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible.

​Gottlieb added: “Our work is not done. We’ll continue taking additional steps to help ensure patients have access to the drugs they need by making generic drug approval more efficient and predictable. We are doing this by continuing to streamline the generic drug review process to get more competitors on the market. We have found that having three or more generic competitors brings prices down more sharply than with only one or two generic competitors.”

And with the record number of approvals, the FDA also set a record for most complete responses in one year. But the gap between this year and years past – 2,548 complete responses have been issued in 2018 vs. 1,603 in FY 2017 and 1,725 in FY 2016 – may be attributed to a spike in applications or because as part of the migration to GDUFA II, there was a bridging process that established a goal date of 31 July for about 800 applications that did not have an official goal date in GDUFA I.


First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information.


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