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  1. Generic Drugs

Complex Generics News

Up-to-date information on FDA’s actions on complex generics

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.


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.

  • On March 15, 2022, FDA approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol.
  • On February 24, 2022, FDA approved the first generic of Apokyn (apomorphine hydrochloride (HCl)) injection, 30 milligram (mg)/3 milliliter (mL) (10 mg/mL).
  • On February 2, 2022, FDA approved the first generic of Restasis (cyclosporine ophthalmic emulsion) 0.05% single-use vials.


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




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.

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.

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