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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, October 12, 2012 - Octaplas

 

From:                    Rana, Pratibha
Sent:                      Friday, October 12, 2012 12:34 PM
To:                         'Simone Meindl'
Cc:                         'Rangetiner, Barbara'; 'Stanley Ammons'
Subject:                 STN 125416/0
Our STN: 125416/0                                                             
 
Octapharma Pharmazeutika Produktionsges.m.b.H.
Attention: Mr. Stanley Ammons
Octapharma USA, Inc.
                         
Dear Mr. Ammons:
 
This communication is in reference to amendment STN 125416/0.12 received August 13, 2012, which contained reports of postmarketing clinical experience. FDA has determined that the amount of clinical information is substantive and the amendment was received within 3 months of the action due date, October 22, 2012, which does not provide adequate time for complete review.  Therefore, your submission will be designated as a major amendment and will extend the review clock of your application by 3 months. The new action due date is January 21, 2013.
 
Please let me know if you have any questions.
 
Pratibha Rana
 
Pratibha Rana, M.S.
Regulatory Project Manager
FDA/CBER/OBRR
Division of Blood Applications
1401 Rockville Pike
Rockville, MD 20852
Office: (301) 827-6124
Fax: (301) 827-2857
email: pratibha.rana@fda.hhs.gov
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