FDA Breaks Generics Drug Record With 128 Approvals Last Month

The FDA recently announced that it approved a record-breaking number of generic drugs in October 2018.
Samantha DiGrande
November 22, 2018
The FDA recently announced that it approved a record-breaking number of generic drugs in October 2018.

In total, the FDA put out 128 approval actions last month. Of these, 110 generic drugs were approved, and 18 other generic drugs were tentatively approved. This number includes 23 first generics for products that previously lacked competition, and 17 complex generics (FDA’s data also include 1 biosimilar adalimumab product).

“The FDA plays an important role in approving high-quality medicines and promoting more generic drug competition. Over the past 2 consecutive years, the agency approved record numbers of generic drugs,” said FDA Commissioner Scott Gottlieb, MD. “Now we’re beginning the new fiscal year by breaking another record, this time with the highest number of approved or tentatively approved generics ever in a month.”

Gottlieb explained that, through the agency’s efforts, generic drugs that entered the market from January 2017 through July 2018 were able to save consumers $26 billion. Additionally, these efforts are also reducing the number of review cycles for generic drug applications, making the process more efficient so the agency is able to dedicate its resources to getting the “quality generic medications” to patients sooner.

Furthermore, last month, the FDA also issued a series of guidance documents aimed at advancing the development of generic transdermal and topical delivery systems. These guidance documents allow for increased transparency from the FDA to applicants seeking approval of generic versions of complex products by explaining how to more efficiently prepare better and more complete applications.

“We’ll continue our efforts to increase competition and help lower costs for patients with our Drug Competition Action Plan and will do so by continuing to advance policies that increase the efficiency of our generic drug program and working to approve high quality generic medicines that meet our standards,” said Gottlieb.


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