Pipex says FDA denies further application review for drug

Tue Jan 29, 2008 8:12am EST
 
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Jan 29 (Reuters) - Pipex Pharmaceuticals Inc PP.A said U.S. health regulators denied further review of a marketing application for its drug, Coprexa, treating a neurologic disorder called Wilson's Disease, pending a safety study, among other demands.

Pipex said the U.S. Food and Drug Administration sent it a "refusal to file," which is not a final determination concerning potential approvability, but delays a full review of the application. (Reporting by Varsha Tickoo in Bangalore; Editing by Jarshad Kakkrakandy)

 
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