Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research
Date: March 11, 2008
From: Jean Makie, M.S., R.D., Regulatory Review Officer
Advertising and Promotional Labeling Branch (APLB) (HFM-602)
Division of Case Management (DCM)
Through: Ele Ibarra-Pratt, RN, MPH, Branch Chief, APLB, HFM-602
To: Pratibha Rana, M.S., RPM, OBRR, DBA, RPMB (HFM-380)
Laura Wood, CMC Committee Chair, OBRR, DH, LBVB (HFM-343)
Kimberly Lindsey, M.D., Medical Officer, OBBR, DH, CRB (HFM-392)
Subject: Summary of Labeling Review for the Summary Basis of Regulatory Action: Artiss (BLA STN: 125266/0)
Throughout the review cycle for BLA STN: 125266/0, APLB has conferred with the Review Committee on the sponsor's proposed labeling for ARTISS. As such, we provide the following summary for consideration and inclusion in the Summary Basis of Regulatory Action:
Section 11: Labeling
- The sponsor's proprietary name, ARTISS, was reviewed by the Advertising and Promotional Labeling Branch (APLB) from a promotional and comprehension perspective and was found to be acceptable on January 18, 2008. OBBR concurred.
- Full Prescribing Information (FPI): APLB reviewed the original FPI submitted by the sponsor. Comments from a promotional and comprehension perspective were provided to OBRR on January 29, 2008. OBBR and APLB comments regarding the FPI were faxed to the sponsor on March 4, 2008. A teleconference was held with the sponsor on March 5, 2008. The sponsor subsequently submitted a revised FPI following the teleconference. APLB reviewed the revised FPI on March 6, 2008 and provided additional comments to OBBR for discussion with the sponsor. A fax containing FDA's comments was sent to the sponsor on March 6, 2008 and discussed on a subsequent teleconference held that afternoon. The sponsor accepted all of FDA's remaining comments and recommendations. FDA and the sponsor also agreed that the following statement will be added underneath the proper name in the Highlights section: "Frozen solution and lyophilized powder for solution for topical application." All FPI issues have been adequately resolved to proceed with final approved labeling.
- Carton and immediate container labels submitted in the original application and revised versions submitted on December 20, 2007 were reviewed by APLB from a promotional and comprehension perspective. Comments on from a promotional and comprehension perspective were provided to OBRR on January 29, 2008 (for original submission) and February 28, 2008 (for revised submission). FDA's comments regarding the sponsor's carton and container labels on were faxed to the sponsor on March 4, 2008. A teleconference was held on March 5, 2008 with the sponsor to discuss the issues raised in the Agency's correspondence. The sponsor submitted revised carton and container labeling following the teleconference. APLB reviewed the revised labeling on March 6, 2008. During the March 6, 2008 teleconference, the sponsor accepted all outstanding recommendations. All carton/container labeling issues have been adequately resolved to proceed with final approved labeling.
- Patient labeling/Medication guide: ARTISS will be administered in a surgical setting only. Patient Information is appropriately provided in the Section 17 of the FPI.
If you have any questions, please contact Jean Makie at 301-827-3028.