BLA 761108/S-021
Page 2
The single-use on body injector will be manufactured and tested at and at
The Ultomiris on body delivery system combination product will be manufactured at Alexion Pharma International Operations Unlimited Company, Alexion Dublin manufacturing Facility (ADMF), Dublin, Ireland, and will be tested for release at and at ADMF, Dublin, Ireland.
DATING PERIOD
The dating period for the 3.5 mL single-dose prefilled cartridge shall be 24 months from the date of manufacture when stored at 2 °C - 8 °C. The date of manufacture shall be defined as the date of final sterile filtration of the formulated drug product.
The dating period for the Ultomiris on body delivery system combination product shall be 24 months from the date of manufacture when stored at 2°C - 8 °C. The date of manufacture shall be defined as the date of final sterile filtration of the formulated drug product in the single-dose prefilled cartridge.
CONTENT OF LABELING
As soon as possible, but no later than 14 days from the date of this letter, submit, via the FDA automated drug registration and listing system (eLIST), the content of labeling [21 CFR 601.14(b)] in structured product labeling (SPL) format, as described at FDA.gov,[1] that is identical to the enclosed labeling (text for the Prescribing Information, Instructions for Use, and Medication Guide) and include the labeling changes proposed in any pending “Changes Being Effected” (CBE) supplements.
Information on submitting SPL files using eLIST may be found in the guidance for industry SPL Standard for Content of Labeling Technical Qs and As.[2]
The SPL will be accessible via publicly available labeling repositories.
Also within 14 days, amend all pending supplemental applications that include labeling changes for this BLA, including pending “Changes Being Effected” (CBE) supplements, for which FDA has not yet issued an action letter, with the content of labeling [21 CFR 601.12(f)] in Microsoft Word format that includes the changes approved in this supplemental application, as well as annual reportable changes. To facilitate review of
- ↑ http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
- ↑ We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
U.S. Food and Drug Administration
Silver Spring, MD 20993
www.fda.gov
Reference ID: 5019210
