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On 09 March 2010, Actelion announced that that it had received a complete response letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for Zavesca® (miglustat) for the treatment of progressive neurological manifestations in adult and pediatric patients with Niemann-Pick type C.

 
 
 

Quotes

Quoted in the press release:

Jean-Paul Clozel, CEO of Actelion:

"We remain committed to bringing an approved treatment to patients suffering from NP-C disease and in this spirit we will continue the dialogue with the FDA."

 
 
 
 

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Jean-Paul Clozel

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