Stelara Approval History

• FDA approved: Yes (First approved September 25th, 2009)
• Brand name: Stelara
• Generic name: ustekinumab
• Company: Centocor Ortho Biotech Inc.
• Treatment for: Psoriasis

Stelara (ustekinumab) is a human monoclonal antibody for the treatment of moderate to severe plaque psoriasis.

FDA Approval History for Stelara

Date	Article
Sep 25, 2009	FDA Approves Stelara (ustekinumab) to Treat Psoriasis
May 27, 2009	FDA Extends Review Timeline for Stelara (ustekinumab) Biologic License Application by Three Months
Dec 19, 2008	FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application
Aug  8, 2008	FDA Extends Review Timeline for Ustekinumab Biologic License Application Three Months
Jun 18, 2008	FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis
Feb  4, 2008	Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA
Dec  7, 2007	Medarex to Receive Milestone Payment for Submission of Regulatory Applications Requesting Approval of Ustekinumab (CNTO 1275) for Treatment of Psoriasis
Dec  4, 2007	Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis

See also...

Stelara (ustekinumab) Consumer Information

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