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news.Centocor Ortho Biotech has announced that FDA has extended the review timeline for its biologic license application (BLA) for Stelara (ustekinumab). The application was filed for approval to market Stelara, for treatment of adult patients with moderate-to-severe plaque psoriasis and who are candidates for phototherapy or systemic therapy.
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The amendment contains testing results to establish self-life of the product. FDA has requested no additional clinical trial for Stelara
Earlier in June 2008, FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) had unanimously recommended Stelara for approval. In December 2008, Centocor Ortho Biotech received complete response letter from FDA requesting additional information, including a proposal for a risk evaluation and mitigation strategy.
Jay P. Siegel, M.D. and Chief Biotechnology Officer, Centocor Ortho Biotech, said: we remain focused on collaborating with the FDA and providing the necessary information to support the review and approval of STELARA for the treatment of adults with moderate to severe plaque psoriasis.