FDA Breaks Generic Drug Approval Record
August 9, 2019 – The U.S. FDA has approved or tentatively approved 1,028 generic drugs since the end of July, breaking the previous record less than a year after it was set.
The announcement came in the form of a Twitter update from current FDA Commissioner Ned Sharpless, MD, who wrote, “I’m pleased to report that FDA’s generic drug program is having another strong year. The approvals [and] tentative approvals from July have put us at 1,028 combined for the fiscal year, breaking our all-time record, which was 971 for [fiscal year] 2018.” The FDA’s fiscal year runs from September 30 to October 1.
Sharpless also remarked on recent changes to the FDA’s generic approval pipeline, describing the agency’s efforts to reduce the number of review cycles for applications “by helping to ensure companies are submitting applications that are ready to approve” and improving the FDA’s efficiency in reviewing applications.
The FDA has approved an increasing number of generics in recent years. In October 2018, it approved the largest number of generics in a single month (128) in the agency’s history. In 2017, the FDA set a record of 937 generic approvals.