Activities Report of the Generic Drugs Program (FY 2021) – FDARA Title VIII Section 807 and 805
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. The tables below provide data on the total number of ANDAs in these two categories that are either awaiting FDA action or awaiting applicant action at the end of each reporting quarter, as well as the number of ANDAs approved in each of these categories during the reporting quarter. The numbers reported below only reflect ANDAs that have been received for review pursuant to section 505(j) of the FD&C Act; if a new ANDA submission has not yet been received for review at the end of the reporting quarter, meaning FDA has not yet made a threshold determination whether the submission is substantially complete, it will be reported in the next quarter after it is received for review.
Section 805 of FDARA requires FDA to include in the reports under section 807 an annual report on the number of pending petitions under section 505(j)(2)(c) of the FD&C Act (commonly referred to as suitability petitions) and the number of such petitions pending a substantive response for more than 180 days from the date of receipt. This information is provided by fiscal year in the last table below.
Reports available:
- FY 2021 ANDAs Subject to Priority Review under Section 505(j)(11) of the FD&C Act
- FY 2021 ANDAs with a Competitive Generic Therapy Designation under Section 506H of the FD&C Act
- FY 2021 ANDAs with a Competitive Generic Therapy Designation under Section 506H of the FD&C Act for which the Secretary has taken action pursuant to Section 506H (c)
- FY 2021 Pending Suitability Petitions under Section 505(j)(2) (c) of the FD&C Act
- Previous Activities Reports
- Additional data on the activities of FDA’s Office of Generic Drugs is available here.
NOTE: Numbers reflect current data at the time of posting and may change based on refreshed counts in our tracking systems.
FY 2021 ANDAs Subject to Priority Review under Section 505(j)(11)* of the FD&C Act
| First Quarter | Second Quarter | Third Quarter | Fourth Quarter | |
|---|---|---|---|---|
| October - December | January - March | April - June | July - September | |
| ANDAs Awaiting FDA Action | 54 | 58 | 59 | 56 |
| ANDAs Awaiting Applicant Action | 18 | 19 | 25 | 31 |
| ANDAs Approved | 6 | 10 | 4 | 9 |
*The counts in this table include ANDAs that were subject to priority review under subparagraphs (A) and (D) of section 505(j)(11) of the FD&C Act, as added by section 801 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA).
FY 2021 ANDAs with a Competitive Generic Therapy Designation under Section 506H of the FD&C Act
| First Quarter | Second Quarter | Third Quarter | Fourth Quarter | |
|---|---|---|---|---|
| October - December | January - March | April - June | July - September | |
| ANDAs Awaiting FDA Action | 114 | 129 | 132 | 146 |
| ANDAs Awaiting Applicant Action | 53 | 55 | 76 | 75 |
| ANDAs Approved | 14 | 15 | 10 | 14 |
| Number of Presubmission Meetings Requested | 0 | 0 | 0 | 1 |
| Number of Presubmission Meetings Held | 0 | 0 | 0 | 0 |
| Number of Product Development Meetings Requested | 4 | 4 | 6 | 7 |
| Number of Product Development Meetings Held | 7 | 5 | 5 | 7 |
FY 2021 ANDAs with a Competitive Generic Therapy Designation under Section 506H of the FD&C Act for which the Secretary has taken action pursuant to Section 506H(c)*
| First Quarter | Second Quarter | Third Quarter | Fourth Quarter | |
|---|---|---|---|---|
| October - December | January - March | April - June | July - September | |
| ANDAs Approved | 0 | 1* | 0 | 1* |
* Section 807(5) of FDARA requires FDA to include information in this report on the effect section 506H of the FD&C Act may have had on the length of time for approval and the number of review cycles for ANDAs with a CGT designation for which FDA has taken action pursuant to section 506H(c) of the FD&C Act. As FDA explained in the guidance for industry Competitive Generic Therapies, the actions FDA may take to expedite development include, as appropriate, product development meetings and pre-submission meetings, and the actions FDA may take to expedite review include mid-review-cycle meetings and striving to act on the ANDA as soon as possible, including prior to the GDUFA goal date.
In FY 2021, there were two approved ANDAs for CGTs for which FDA took action to expedite the development and review of the applications; specifically, we either held a product development or presubmission meeting with the applicant prior to submission of the ANDA, held a mid-review-cycle meeting during the first review cycle, and took actions to expedite the review of the ANDAs.
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 these ANDAs were both approved after two review cycles and that their approval times were faster than the mean and median approval times for the quarters in which they were approved. Through our pre-ANDA program, the applicants for these ANDAs were able to receive targeted feedback on either the format and content of the ANDA to be submitted or on specific scientific issues or questions regarding their ANDA development program. The opportunity to obtain this kind of targeted advice from FDA likely shortened development time for the ANDAs and allowed the applicants to avoid deficiencies that may have led to a delay in the approval of the ANDAs.
FY 2021 Pending Suitability Petitions under Section 505(j)(2) (C) of the FD&C Act*
| FY 2021 | |
|---|---|
| Petitions Pending a Substantive FDA Response | 199 |
| Petitions Pending a Substantive FDA Response for More than 180 Days of Receipt | 184 |
*These numbers are reported annually and will be posted when available.