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.

• 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.

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.

• In August 2022, FDA published a new batch of 48 draft product-specific guidances (PSGs). 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. FDA also updated the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page, which is updated each time FDA publishes a new batch of PSGs.
• In May 2022, FDA published a new batch of 37 draft product-specific guidances (PSGs). 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. FDA also updated the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page, which is updated each time FDA publishes a new batch of PSGs.
• In April 2022, FDA published a new draft guidance for industry, “Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.” The guidance is intended to assist applicants preparing an abbreviated new drug application (ANDA) by describing how FDA intends to evaluate a request for a waiver, with regard to a pH adjuster, under 21 CFR 314.99(b) of the requirement in 21 CFR 314.94(a)(9)(iii) and (iv).
• In April 2022, FDA published a new Manual of Policies and Procedures (MAPP) 5240.10, “Classifying Approved New Drug Products and Drug-Device Combination Products as Complex Products for Generic Drug Development Purposes.” The MAPP details FDA’s policies and procedures for classifying which approved new drug products and CDER-led drug-device combination products are complex products for generic drug development purposes.
• In February 2022, FDA published a new batch of 43 draft PSGs. FDA also updated the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page.

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.