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, Psoriatic Arthritis

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

FDA Approval History for Stelara

DateArticle
Sep 23, 2013Approval Stelara (ustekinumab) Receives FDA Approval to Treat Active Psoriatic Arthritis
Sep 25, 2009Approval FDA Approves Stelara (ustekinumab) to Treat Psoriasis
May 27, 2009FDA Extends Review Timeline for Stelara (ustekinumab) Biologic License Application by Three Months
Dec 19, 2008FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application
Aug  8, 2008FDA Extends Review Timeline for Ustekinumab Biologic License Application Three Months
Jun 18, 2008FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis
Feb  4, 2008Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA
Dec  7, 2007Medarex to Receive Milestone Payment for Submission of Regulatory Applications Requesting Approval of Ustekinumab (CNTO 1275) for Treatment of Psoriasis
Dec  4, 2007Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis

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