Key Takeaways
- Full ANDA approvals dropped in FY 2024, compared to the previous year, while submissions increased slightly.
- Complete response letters also dropped, but quarterly mean and median approval times increased.
- The data may help shape the upcoming user fee reauthorization negotiations, which will begin in 2025.
Nearly 90 fewer generic drug applications gained full approval in fiscal year 2024 than the previous year. Coupled with declines in several other Office of Generic Drug actions, the performance may complicate the upcoming user fee reauthorization negotiations.
The US Food and Drug Administration granted full approval to 694 ANDAs and tentative approval to another 162 applications in fiscal year 2024, which ended on 30 September. (See charts at the end of the story.)
Both were significantly less than FY 2023. The full approval total fell 11.2%, while the tentative approval figure fell 5.8%.
At the same time, first-time generics, or applications that are the first generic approved for a reference product, plummeted 21.3% from 89 in FY 2023 to 70 in FY 2024. The FY 2024 total was the lowest recorded since the agency began reporting the statistic in FY 2020.
And OGD, as well as industry, continued to struggle to increase the number of ANDAs cleared after one review cycle. The rate ticked down to 17.6% in FY 2024 and still has never reached 20% since the agency began reporting first-cycle approvals in FY 2018.
About 40% of ANDAs are approved after the second cycle, but quarterly mean full approval times hovered between 39 and 42 months in FY 2024. Quarterly median full approval times ranged from 26 months to more than 29 months.
Complete response letters reached their lowest level since FY 2015, which generic drug sponsors will like. The agency issued only 1,414 in FY 2024, the sixth consecutive year that the total has been less than the previous year.
OGD Director Iilun Murphy, like her predecessors, has called for improved application quality to reduce review cycles and increase approvals. She also has said the FDA can help facilitate development of new BE approaches an analytical tools.
But the OGD action data may raise questions about agency performance with generic drug user fee reauthorization talks beginning in mid- to late-2025. FDA and industry officials will determine the extent of fee increases and other service changes to expand the program beyond 2027.
ANDA Submissions Increased Slightly
FDA actions are in part dependent on the number of submitted applications, which the agency cannot control.
Consolidation and other industry dynamics have led to fewer applications. But ANDA submissions increased slightly in FY 2024 to 740, after 733 were sent to the agency in FY 2023.
However, after nine out of 10 years with at least 800 ANDAs submitted, the total now has been below that figure for two straight years.
Complex Product Applications Grow
Complex products, which take longer to develop and review than traditional generics, increased in number and share of the submission total, which may at least partially explain the longer approval times.
The FDA reported 138 complex product submissions in FY 2024, up from 121 in FY 2023, the first year the figure was reported. In FY 2023, complex product submissions were 16.5% of the total, while in FY 2024, they constituted 18.6% of the total.
FDA officials have been working for years to streamline complex generic development, including through the parallel scientific advice program and other international harmonization efforts.
Below is a graphic with more data on the generic drug user fee program since its inception, including FY 2024 figures.
