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FDA Delays Centocor’s BLA for Psoriasis Drug

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Centocor’s BLA for ustekinumab for the treatment of plaque psoriasis has been delayed by three months to December 2008. Centocor filed the BLA late in 2007.
   
The FDA extended the review period in order to review amendments to the application provided by Centocor within the last three months. The FDA has not requested additional clinical trials.
   
In June, the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) unanimously recommended ustekinumab for approval. The committee provides recommendations based on its evaluation but the FDA has the final say on approval. Ustekinumab is also under review by the EMEA.

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