BRIEF—Record number of FDA generic approvals in October

The US Food and Drug Administration is providing a summary of the generic drug approval actions for the month of October 2018 as part of its efforts to improve patient access to high-quality, lower cost, safe and effective medicines.

In October, the FDA approved 110 generic drugs and tentatively approved 18 generic drugs, for a total of 128 approval actions. This included 23 first generics for brands that lacked competition and 17 complex generics.

In October, the FDA also issued a series of guidance documents that will advance the development of generic transdermal and topical delivery systems (TDS).

The increased transparency and predictability provided by these recommendations gives applicants seeking FDA approval of generic versions of these complex products a better understanding on how to efficiently and successfully develop these products, and prepare better and more complete applications.

The FDA also issued 25 related product-specific guidance documents to provide recommendations for applications for such complex products.

Of these, 23 were revised to update newer scientific understanding and two were new guidances.

These documents help assist industry in identifying appropriate science-based methodologies and critical evidence for development and approval of generic TDS products.