Answers
01/27/1994

<TITLE>Committee Recommends Against Approving Therafectin</TITLE>
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T94-7                                      Susan M. Cruzan
Jan. 27, l994                              (301) 443-3285

           Committee Recommends Against Approving Therafectin

     On Jan. 27, FDA's Arthritis Advisory Committee voted to recommend that
Therafectin (amiprilose HCl) not be approved for treatment of rheumatoid
arthritis because of a lack of sufficient data.  
     Last September, after weighing all the evidence in the application,
FDA determined that the drug was not approvable.  FDA convened the advisory
committee to obtain expert advice to assist the agency in its further
deliberations about Therafectin.   
     The advisory committee concluded that adequate evidence of
effectiveness and safety had not been provided to support marketing
approval. 
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