The United States Food and Drug Administration (FDA) approved – or tentatively approved – a record of 126 generic drugs in July 2018. Of the 126 approvals, 96 generic drugs were fully approved and 30 were tentatively approved.
In July, the FDA also sent an annual high of 357 complete response letters, which are sent to companies to communicate that the agency has completed its review of a new or generic drug application and it will not approve the generic in its present form.
Prior to the introduction of a user fee program in 2012, the FDA had a backlog of over 10,000 generic drug applications to work through. Since the introduction of that program, however, the agency receives money for each application, which allows them to use those funds to improve operational efficiency. One goal of the current Administration has been to bring down generic drug approval times, as they believe this is one of the better ways to lower drug prices. This latest record suggests that these attempts are paying off as the agency currently tries to review all drug applications within a window of 10 months.
Below are the current charts, showing approvals, submissions, and meeting requests from October 2017 through July 2018. Across the board, it seems as though July 2018 saw record numbers in just about every category.
