FDA Issues Final Guidance on Liposome Drug Products

The FDA published a final guidance for industry on what applicants should submit for NDAs and ANDAs for liposome products.

The guidance updates the agency’s revised draft issued in October 2015 and includes information on chemistry, manufacturing and controls; bioavailability and bioequivalence; and labeling for liposome drug products with some technical changes. It does not include recommendations for BLAs, although “many scientific principles in this guidance may also apply,” the agency said.

Manufacturers should include all components, listed by their established names, in the labeling — including drug substance, lipids, nonlipid components of the liposome and all nonliposome inactive ingredients.