
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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