Inside FDA's Office of Generic Drugs

In the 12 months that ended Sept. 30, 2025, FDA approved 689 generic drug applications and tentatively approved 250 more, according to the agency's fiscal 2025 GDUFA performance report to Congress¹. Over the same 12 months the office that reviews those applications sent out 1,281 complete response letters, the formal notice that an application cannot be approved as submitted, according to its monthly activity report for fiscal 2025².

That office is FDA's Office of Generic Drugs, known inside the agency as OGD. It sits within the Center for Drug Evaluation and Research and handles the abbreviated new drug application, or ANDA, that every generic needs before it can be sold in the US. FDA says on OGD's own page⁵ that generics "account for more than 90 percent of prescriptions filled in the United States."

OGD's yearly numbers say a lot about how generic competition actually arrives. Most applications are not approved the first time FDA reviews them. Hundreds sit finished but blocked by patents. And the count of approvals in a year says little about how much money those approvals save.

How the office is organized

According to FDA's directory of OGD offices and divisions⁶, updated in October 2026, the office has an immediate office and five sub-offices. Each one handles a different part of the job.

Manufacturing quality is a shared job. CDER's Office of Pharmaceutical Quality⁷ says it integrates "the assessment of drug applications with the evaluation of manufacturing facilities" for new drugs and generics alike, so the chemistry and plant side of an ANDA runs through that office alongside OGD's work. Our explainer on manufacturing quality rules covers what those assessors look for.

What the yearly numbers show

OGD used to tell its story through a narrative annual report. The most complete current figures now come from two places: the GDUFA performance reports FDA sends Congress each year, and a monthly activities dataset FDA now publishes through its FDA-TRACK performance dashboard⁴. All of these count by federal fiscal year, which starts Oct. 1.

Sources for the table are FDA's monthly activity reports for fiscal 2024³ and fiscal 2025 and the fiscal 2026 dataset on FDA-TRACK, which ran through August 2026 when GxRadar downloaded it. Receipts are raw counts before FDA screens applications for completeness.

Two ratios stand out. In fiscal 2025, 137 of 689 approvals came on the first review cycle, about one in five. And FDA issued nearly two complete response letters for every approval. Most generics are approved only after the applicant fixes the problems listed in a complete response letter and resubmits, sometimes more than once.

Harder products get their own count. An OGD presentation at FDA's Generic Drugs Forum in April 2026⁸ said the fiscal 2025 actions included 125 complex generic ANDAs and 107 with a competitive generic therapy designation.

Calendar-year counts tell a similar story. GxRadar's tally of original ANDA approvals in FDA's Drugs@FDA data on openFDA¹¹ shows a peak of 833 in 2017, 648 in 2025 and 575 in 2026 through Oct. 27. Our approvals page charts every year since 1984, a total of 19,593 original approvals.

Tentative approval and the patent queue

A tentative approval is FDA's way of saying the science is done but the law is not. FDA's activity reports define it plainly: when a generic "is ready for approval but cannot be approved due to a patent or exclusivity" on the brand, FDA issues a tentative approval letter. The product cannot be sold until that barrier lifts, through patent expiry, a court ruling, a settlement date, or the end of another company's 180-day exclusivity.

That queue is large. The FDA-TRACK dataset shows 555 ANDAs sitting in tentative-approval status at the end of August 2026. Another 1,235 had received complete response letters and were waiting on the applicant, and 1,184 were under FDA review. The patent and exclusivity rules behind those holds are described in our pieces on Paragraph IV certifications and the Orange Book.

How a review moves

An ANDA first goes through filing review, where FDA checks that it is complete enough to review at all. Incomplete ones get a refuse-to-receive letter. FDA sent 18 of those in fiscal 2025 and 11 in fiscal 2026 through August, according to the monthly reports, a small number set against 600 applications received in fiscal 2025.

Once filed, the application gets a goal date. Under the GDUFA III commitment letter¹⁰, which covers fiscal 2023 through 2027, FDA aims to act on 90 percent of standard original ANDAs within 10 months, and on priority ones within eight months when the applicant sends facility information at least 60 days before filing. Priority status goes to applications that meet FDA's prioritization policy, which is aimed at public health needs. User fees support this work; our GDUFA explainer covers the fees and the promises attached to them.

During review, project managers coordinate bioequivalence, labeling, quality and facility assessments, plus clinical or toxicology consults where needed. Reviewers can send information requests and discipline review letters mid-cycle. FDA logged 494 information requests in October 2025 alone. The cycle ends with an approval, a tentative approval, or a complete response letter listing deficiencies. Our step-by-step guide to how a generic drug gets approved covers what goes into the application itself.

Meeting a 10-month goal date is different from approving a drug in 10 months, because each resubmission starts a new clock. In the first three quarters of fiscal 2026, the median time from FDA's acceptance of an original application to its first full approval ran between about 20 and 28 months, according to the FDA-TRACK dataset.

Much of OGD's work happens before any application arrives. Developers send controlled correspondence, written questions about a planned product. FDA received 3,916 of them in fiscal 2025, the monthly report shows. The office also publishes the product-specific guidances that tell developers which studies FDA expects for a given drug.

Approvals and savings are not the same count

FDA's economists estimate savings each year by tracking prices in the 12 months after approval. Their study of 2023 approvals⁹, published in November 2025, put net savings at $18.6 billion from 773 full approvals. First generics accounted for $2.4 billion of that, about 13 percent. Nine of the top 10 products by savings were later generics entering markets that already had some competition. The same study notes that the 2019 cohort produced nearly $25 billion and the 2020 cohort just under $11 billion, a gap it attributes to the mix of products approved rather than the number. Our piece on why generic prices fall as competitors enter explains the mechanism, and the first generics explainer looks at the first entrant in each market.

What is changing in 2026 and 2027

Two items in the April 2026 forum presentation will shape OGD's correspondence with applicants. The Consolidated Appropriations Act enacted Feb. 3, 2026, requires FDA to name the specific inactive ingredient behind a failed sameness check, and to say by how much it deviates, when a proposed generic that must match the brand's formulation does not. The requirement applies to submissions pending on or filed after that date. Separately, the fiscal 2025 performance report¹ says FDA revised more than 826 draft product-specific guidances to align with an international bioequivalence standard finalized in October 2024, cutting the recommended number of bioequivalence studies for many immediate-release tablets and capsules from two to one.

The larger deadline is funding. FDA's GDUFA IV page¹² notes that the current authority expires in September 2027 and that new legislation will be required for FDA to keep collecting generic drug user fees. The agency held a public meeting on proposed enhancements for fiscal 2028 through 2032 on Sept. 17, 2026; the proposed commitment letter then goes to Congress.