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Labeling Letter - Novoeight
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
- We have reviewed the package insert submitted on August 23, 2013, and request changes be made in accordance with the attached MS Word document.
- You may use the proprietary name with the initial letter capitalized (Novoeight) in the print package insert. However, please note that the name will appear as NOVOEIGHT in SPL (DailyMed, etc.).
- Please delete “Plasma/Albumin Free” from the proper name and adjust the proprietary name in the carton and vial labels, and re-submit the mock-up.
- Please note that the actual FVIII activity values (determined by the one-stage clotting and the chromogenic substrate assays) should be stated on carton and vial for product distribution (please refer to September 9th, 2013 CMC Information Request for further details).
- Please use definitions “reconstitution”, “reconstituted” in sections 2.2 and 2.3 (definitions “mixing”, “mixed” were deleted).
- You may request a teleconference if any clarifications are needed.