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USFDA's New WebPage: For Complex Generics

Friday the USFDA agency published a new web page to share the most recent FDA actions and activities related to complex generics, which will provide the access to safe, effective, high-quality, and more affordable generic drugs.

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.

This page features news, information, and additional resources about FDA’s activities that support the development and approval of complex generic drugs and will be updated regularly with information about recent Agency actions related to complex generics, including:

  • notable approvals

  • guidance documents

  • research

  • events

The reason to open a webpage is to ease the information, as these products are generally harder to develop, fewer exist, resulting in less market competition. This means that complex generics may be more expensive and less accessible to the patients who need them.

Follow this New WebPage to understand and explore more about Complex Generics.


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