FDA to Consider Ferrioprox on 9/14

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FDA to Consider Ferrioprox on 9/14
« on: July 26, 2011, 08:11:50 PM »

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Offline Andy Battaglia

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Re: FDA to Consider Ferrioprox on 9/14
« Reply #1 on: July 27, 2011, 03:02:04 AM »
Thanks Craig.

I hope those in the US will consider sending in submissions to ask for approval of this much needed drug. There is no valid reason for the FDA to reject this drug, and its use around the world for over twenty years has well established its value to thalassemics. The voices of thals themselves need to be heard on this.

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CAF believes that patients in the United States need more chelation options so that treatment can be tailored to the specific needs of each individual patient and supports this application.  We  encourage interested members of the thalassemia community to submit their views on the need for this oral chelator to the Committee.
Written submissions must be received by the FDA no later than August 30, 2011.  Submissions should be submitted by mail to Caleb Briggs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Building 31, Room 2417, Silver Spring, MD   20993-0002; by email to ODAC@fda.hhs.gov or by fax to (301) 847-8533.
After sending your submission to the FDA, please forward a copy to us (Cooley's Anemia Foundation, 330 Seventh Avenue #200, New York, NY  10001  or c.butler@cooleysanemia.org). 
Andy

All we are saying is give thals a chance.

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Offline Narendra

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Re: FDA to Consider Ferrioprox on 9/14
« Reply #2 on: August 03, 2011, 05:40:29 PM »
Thanks folks.

So as Andy mentions please send your submissions as soon as possible. The address to send the submission is
Caleb Briggs
Center for Drug Evaluation and Research,
Food and Drug Administration,
10903 New Hampshire Avenue,
Building 31, Room 2417,
Silver Spring, MD 20993-0002

or by email to ODAC@fda.hhs.gov
or by fax to (301) 847-8533.

 

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