FDA extends review of BLA for ustekinumab
The US Food and Drug Administration has extended the review timeline for the Biologic License Application for US firm Centocor's ustekinumab, a subcutaneous biologic therapy, by three months to December. The application, filed by Centocor late in 2007, seeks approval to market ustekinumab for the treatment of adult patients with chronic moderate-to-severe plaque psoriasis.
The FDA extended the review period to provide additional time for review of amendments to the application provided by Centocor within the last three months. The FDA has requested no additional clinical trials.
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