ANDA review goal dates and how often generics clear the first cycle

FDA approved 689 generic drug applications in fiscal 2025. Only 137 of them, about one in five, were approved the first time the agency reviewed them, according to FDA's monthly activity report for that year⁶. Over the same 12 months, the agency sent 1,281 complete response letters telling applicants their submissions could not be approved as filed.

Those numbers coexist with a review system that, on paper, runs on time. Under the generic drug user fee program, FDA promises to act on 90 percent of standard applications within 10 months, and its reports to Congress show it usually meets that goal. The catch is the word "act." A rejection letter counts as an action as much as an approval does.

This piece explains how the goal dates for an abbreviated new drug application (ANDA) are set, how FDA has performed against them, and why the typical generic still takes about two years from filing to approval.

What the 10-month clock promises

Goal dates come from the commitment letter that FDA and industry negotiate for each five-year round of the Generic Drug User Fee Amendments. The current one, the GDUFA III commitment letter¹, covers fiscal 2023 through 2027. FDA's fiscal 2025 performance report² defines acting on an ANDA as issuing an approval, a tentative approval, a complete response letter or a refuse-to-receive letter.

Priority status goes to submissions FDA identifies as eligible for expedited assessment under its written prioritization policy, CDER's MAPP 5240.3, which the commitment letter cites. In fiscal 2025, FDA received 388 ANDAs for standard review and 80 for priority review, the performance report shows.

How FDA has done against the goals

Final results exist for the first two GDUFA III cohorts. For applications received in fiscal 2023, FDA acted on time on 92 percent of 569 standard original ANDAs, above the 90 percent target, and on 88 percent of 155 priority ones, below it. Counting approvals that came in the 60-day imminent action window, which the commitment letter treats as on time, the priority figure rose to 93 percent.

The fiscal 2024 cohort did better. As of Sept. 30, 2025, FDA had acted on 500 of 559 standard originals, 93 percent of them on time, and on 160 of 174 priority originals, 96 percent on time. The report also counts large misses. In the fiscal 2023 cohort, 24 original ANDAs missed their goal date by more than six months and 12 by more than a year. In the fiscal 2024 cohort, two missed by more than six months.

Letters, extensions and imminent actions

Most of the action happens before the goal date. Under the commitment letter, information requests and discipline review letters "do not stop the assessment clock." In the first cycle, each review discipline except labeling is supposed to send its questions by the midpoint, marking deficiencies as major or minor. A response to a major deficiency counts as a major amendment and pushes the goal date out by the months that amendment type allows.

Late in a cycle, FDA can also send questions about minor problems that, if fixed, could lead to approval in the same cycle. If the applicant's answer resolves them, FDA may extend the goal date by 90 days. A letter sent without a response date, the commitment letter warns, "likely will signify a forthcoming CRL."

FDA can also work past a goal date when it judges an approval or tentative approval possible within 60 days, for example when a patent or exclusivity barrier lifts just after the date. These imminent actions accounted for 85 of fiscal 2025's 689 approvals, according to the activity report, and 112 of the 650 approvals from October 2025 through August 2026, according to the FDA-TRACK generic drug dashboard⁷. Tentative approvals and the patent rules behind them are covered in our explainers on tentative approval and 180-day exclusivity.

How often the first cycle is the last

FDA's monthly reports count first-cycle approvals, meaning approvals that came without any prior complete response letter. The share has hovered just under one in five for five years.

Sources are FDA's activity reports for fiscal 2022³, 2023⁴, 2024⁵ and 2025⁶, and the FDA-TRACK dataset for fiscal 2026, which ran through August when GxRadar downloaded it. The share is GxRadar's arithmetic.

This share describes the approvals in a given year. It is a different measure from the chance that a new application is approved on its first try, because approvals in any year include applications filed years earlier. A cohort view comes from an April 2025 presentation by the Office of Generic Drugs⁸, which found that roughly 38 to 40 percent of ANDAs submitted in fiscal 2018 and 2022 were approved by the second cycle. For complex products the figure was about 25 percent. The reasons applications fail, led by facility and manufacturing problems, tie back to the plant rules described in our CGMP explainer.

From filing to approval in months

Because each resubmission gets a new goal date, total time to approval is far longer than 10 months. FDA's activity reports measure it from the date an application is accepted for filing to its first full approval. In fiscal 2025 the quarterly median ranged from 22.6 to 26.2 months. In the first three quarters of fiscal 2026 it was 25.7, 20.3 and 27.6 months.

User fee reports measure by cohort instead. For ANDAs received in fiscal 2023 and approved by Sept. 30, 2025, the median approval time was 511 days and the median number of review cycles was two. Applications approved on their first cycle took a median of 355 days. FDA notes these figures will lengthen as slower applications from the same cohort are approved.

Our step-by-step guide to how a generic drug gets approved covers the application itself, and our profile of the Office of Generic Drugs describes who does the reviewing. Year-by-year approval counts since 1984 are on our approvals page.

What changes next

Developers can try to shorten the path before filing. FDA's pre-ANDA meeting program for complex generics is meant to cut the number of review cycles, and our GDUFA explainer covers the fees that pay for the reviews.

FDA's proposed GDUFA IV commitment letter⁹ for fiscal 2028 through 2032 keeps the 10-month standard goal. It adds a 120-day goal date extension when a surveillance inspection of a facility named in the application produces a potential Official Action Indicated alert within 90 days of the goal date and no other major deficiencies remain. GDUFA III authority expires in September 2027, according to FDA's GDUFA IV page¹⁰, and new legislation is required for FDA to keep collecting the fees that fund these reviews.