DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
Our STN: BL 125416/0
Octapharma USA, Inc.
Attention: Mr. Stanley Ammons
121 River Street, 12th floor
Hoboken, NJ 07030
Dear Mr. Ammons:
This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.
We have completed an initial review of your application dated December 22, 2011 for Pooled Plasma, Solvent Detergent Treated (Human) to determine its acceptability for filing. Under 21 CFR 601.2(a) we have filed your application today. The review goal date is October 22, 2012. This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted.
We will contact you regarding your proposed labeling no later than September 22, 2012. If postmarketing study commitments (506B) are required, we will contact you no later than September 22, 2012.
While conducting our filing review, we identified the following potential review issue:
In accordance with the ICH E2E Pharmacovigilance Planning Guideline, April 2005, it is requested that Octapharma submit a pharmacovigilance plan containing the elements delineated in ICH E2E, which can be accessed at http://www.fda.gov/RegulatoryInformation/Guidances/ucm129411.htm
). Rapid submission of this plan in a complete form will facilitate timely review of the application.
We are providing the above comments to give you preliminary notice of potential review issues. Our filing review is only a preliminary evaluation of the application and is not indicative of deficiencies that may be identified during our complete review. Issues may be added, deleted, expanded upon, or modified as we review the application. If you respond to these issues during this review cycle, we may not consider your response before we take an action on your application. Following a review of the application, we shall advise you in writing of any action we have taken and request additional information if needed.
If you have any questions, please contact the Regulatory Project Manager, Pratibha Rana, at (301) 827-6124.
Regulatory Project Management Branch
Office of Blood Research and Review
Center for Biologics
Evaluation and Research