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Panel: Orange Book may add RLD strengths for presentation or volume differences
Summary
FDA staff said the Orange Book team sometimes expands RLD strengths and potencies to reflect different packaging, volumes, or presentations; staff invited submitters to email specific examples to the Orange Book mailbox for case-by-case review.
An attendee asked why some reference listed drugs now show additional potencies or strengths in the Orange Book that were not previously listed.
An Orange Book staffer (S7) replied the Orange Book "is constantly looking at the RLD itself" and that some RLDs may have different volume sizes or presentations prompting an expansion of listed strengths. The staffer encouraged specific examples to be sent to the Orange Book email for direct review.
Why this matters: RLD listings and strengths in the Orange Book can affect whether a proposed generic product requires a suitability petition or a different approval pathway. Staff said they will accept case-specific inquiries to explain individual updates.
