USA – 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…