Centocor Inc. announced Friday that it will withdraw itsproduct license applications (PLAs) for Myoscint and Fibriscintbecause "certain defiencies were found, which have beenbrought to the attention of and discussed with the Food andDrug Administration."
The company said it intends to re-analyze the available datarelating to Myoscint, a cardiac imaging agent, and submit arevised application. More clinical testing will be necessary tosupport any new application for Fibriscint, a blood-clot imagingagent, the Malvern, Pa., company said.
Analyst Carol Werther of Cowen & Co. in Boston said theimaging agents were supposedly candidates for out-licensing,and that Friday's announcement is "clearly a setback."
Centocor's stock (NASDAQ:CNTO) closed Friday at $7 a share,down 25 cents.
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