Activities Reports of the Generic Drugs Program - FDARA Title VIII Sections 807 and 805 (FY 2018)

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.

Additional data on the activities of FDA’s Office of Generic Drugs is available here, including the Monthly Performance Report and the GDUFA Quarterly Report.

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	2	6	16	29
ANDAs Awaiting Applicant Action	0	0	0	3
ANDAs Approved	0	0	0	0

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	3	16	33	45
ANDAs Awaiting Applicant Action	0	0	0	2
ANDAs Approved	0	0	0	3
Number of Presubmission Meetings Requested	1	0	0	1
Number of Presubmission Meetings Held	0	0	0	0
Number of Product Development Meetings Requested	2	1	2	1
Number of Product Development Meetings Held	0	0	0	1

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 Awaiting FDA Action	0	0	0	0
ANDAs Awaiting Applicant Action	0	0	0	0
ANDAs Approved	0	0	0	0

Pending Suitability Petitions under Section 505(j)(2)(C) of the FD&C Act
	FY 2018
Petitions Pending a Substantive FDA Response	158
Petitions Pending a Substantive FDA Response for More than 180 Days from the Date of Receipt	148

NOTE: Numbers reflect current data at the time of posting and may change based on refreshed counts in our tracking systems.

*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).