First Quarterly Reports for Competitive Generic Therapy Designation and Priority Review Applications Under Section 807 of the Act

“Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review under section 505(j)(11) of the Federal Food, Drug, and Cosmetic (FD&C) Act and certain ANDAs with a competitive generic therapy designation under section 506H of the FD&C Act.” These reports were issued on March 7, 2025 and can be found here.

The two charts below provide data on each of the competitive generic therapy (CGT) categories under Section 506 of the Act and describe, for the most part, the required reporting metrics required by the Act.

The numbers reported in the chart for ANDAs awaiting FDA or applicant action are for those ANDAs that have received CGT designation. Remember that for ANDAs designated as CGT applications, once the first one is approved, the others could be blocked by 180-day exclusivity but will still retain their designation. Thus, it is not possible to tell from the number of CGT applications approved how many of the 28 ANDAs approved received 180-day CGT exclusivity, because while individual applications could have been designated, they may not have been the first approved. It is also possible to receive a CGT designation for an ANDA that will not ultimately be eligible for CGT exclusivity due to patent(s) or exclusivity(ies) applying to the RLD at the time the CGT-designated ANDA is submitted for review.

The second chart presents the number of ANDAs for which the FDA has taken action to expedite development of a CGT application including “product development meetings and pre-submission meetings, and the actions FDA may take to expedite review include mid-cycle-review meetings, enhanced mid-cycle-review meetings and striving to act on the ANDA as soon as possible, including prior to the GDUFA goal date.” The FDA is also required to report on the time for approval and the number of review cycles it takes to approve the designated ANDAs.

In the first quarter of FY 2025, the FDA has exercised additional action for only two ANDAs designated for CGT under Section 506H(c) of the Act so far. However, the FDA did not actually report the length of time or the number of review cycles for these two applications, but rather made a general statement:

“It is difficult to assess the effect the actions to expedite the development and review of these CGTs may have had on the length of time to approval and the number of review cycles for approval without a larger sample of applications, including applications for comparable products for which expedited development and review actions were not taken to use as a comparison group. We note, however, that the approval time for these ANDAs was faster than the mean and median approval time for the quarter in which they were approved.”

It is not known why the FDA did not report these two metrics (the actual length of time or number of review cycles that it took to approve these two ANDAs).

There is also a report on the receipt of and actions taken on ANDA suitability petitions that is supposed to be issued quarterly; however, the FDA notes that, since ANDA suitability petitions did not receive goal dates prior to FY 2024, it will report these figures only annually.

The FDA also reported on the ANDAs that received priority review under section 505(j)(11) of the Act. The chart below satisfies the reporting requirement for these metrics.