Complex Generics News

Generally, complex generics are products that have complex active ingredients, formulations, dosage forms, or routes of administration, or are complex drug-device combination products. Generics of complex brand name drugs (i.e., reference listed drugs) can be more difficult to develop. As such, a complex drug may be less likely to have an available generic.

To help patients access important medical treatments, FDA’s Center for Drug Evaluation and Research works to better understand the scientific issues impacting complex generic development and assessment. FDA shares these scientific insights publicly, further enabling generic drug applicants to develop complex products and helping to ensure that applicants have the necessary information to prepare complete submissions.

This page features news, information, and additional resources about FDA’s activities that support the development and approval of complex generic drugs.

Approvals

Every year, FDA approves or tentatively approves hundreds of generic drug applications, including dozens of complex generics. Below is a list of recent notable complex generic approvals.

Events

Below is a list of recent and upcoming events regarding complex generics.

Upcoming

Recent

Guidances

Guidance documents represent FDA’s current thinking on a topic and may discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. Below is a list of recently published guidances and other documents related to complex generics.

Product-specific guidances (PSGs) provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, thereby helping to streamline generic drug product development by industry and ANDA assessment by FDA.

• In March 2026, FDA published the final guidance for industry entitled “Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs.” This guidance finalizes the draft guidance for industry of the same title issued on October 21, 2022. This final guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal membranes, referred to as “topical products.” This final guidance provides recommendations for physicochemical and structural (collectively, “Q3”) characterizations that can be used to identify the dosage form of a proposed generic (test) topical product, and to describe properties of the drug product that may be critical to its performance (to support a demonstration of bioequivalence (BE)). This final guidance provides recommendations on the types of characterizations that constitute a basic and comprehensive Q3 characterization. This final guidance also describes the concepts of “sameness,” “similarity,” and “difference” in comparing Q3 characterizations of two topical products, and how showing “Q3 sameness,” “Q3 similarity,” or “Q3 difference” between a test topical product and the reference standard may impact what additional evidence may be recommended to demonstrate BE, as part of a comparative product characterization-based approach. This guidance does not address Q3 characterization of topical products for purposes of product quality control.
• In May 2023, FDA published 47 draft PSGs, of which 25 were for complex products (14 new and 11 revised). FDA also updated the Upcoming Product-Specific Guidances for Generic Drug Product Development web page, which is updated each time FDA publishes a new batch of PSGs.
• In May 2023, FDA published an update to Manual of Policies and Procedures (MAPP) “Assessment of Bioequivalence Studies with Clinical Endpoints in ANDAs” (MAPP 5210.4 Rev. 3).
• In April 2023, FDA published two revised draft guidances related to the design and conduct of studies for evaluating transdermal and topical delivery systems (TDS) submitted abbreviated new drug applications (ANDAs):

Research-related Articles

FDA’s GDUFA Science and Research Program provides new tools for FDA to evaluate generic drug equivalence and for industry to efficiently develop new generic products. Below are recent FDA articles focusing on complex generics.

Additional Resources

Further information on complex generics is available at the links below.

• Content current as of:

  03/20/2026

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