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, M.S.
Regulatory Project Manager
Division of Blood Applications
1401 Rockville Pike
Rockville, MD 20852
Office: (301) 827-6124
Fax: (301) 827-2857
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