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FDA touts record-breaking number of October generic approvals

In October, the Food and Drug Administration approved 110 generic drugs and tentatively approved 18 generic drugs for a total of 128 approval actions.

The total included 23 first generics for brands that lacked competition and 17 complex generics.

“The FDA plays an important role in approving high-quality medicines and promoting more generic drug competition. Over the past two consecutive years, the agency approved record numbers of generic drugs,” FDA commissioner Scott Gottlieb said. “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.”

In October, the FDA also issued a series of guidance documents that will advance the development of generic transdermal and topical delivery systems, or 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,” Gottlieb said. “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.”
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