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Stelara FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved September 25, 2009)
Brand name: Stelara
Generic name: ustekinumab
Dosage form: Injection
Company: Janssen Biotech, Inc.
Treatment for: Psoriasis, Psoriatic Arthritis, Crohn's Disease, Maintenance, Ulcerative Colitis

Stelara (ustekinumab) is a human interleukin-12 and -23 antagonist indicated for the treatment of moderate to severe plaque psoriasis (Ps), active psoriatic arthritis (PsA), moderately to severely active Crohn’s disease (CD), and moderately to severely active ulcerative colitis.

Development timeline for Stelara

DateArticle
Aug  1, 2022Approval Stelara (ustekinumab) Approved by the U.S. Food and Drug Administration to Treat Pediatric Patients with Active Psoriatic Arthritis
Jul 30, 2020Approval FDA Approves Stelara (ustekinumab) for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis
Oct 21, 2019Approval Janssen Announces FDA Approval of Stelara (ustekinumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis
Oct 13, 2017Approval Janssen Announces FDA Approval of Stelara (ustekinumab) for the Treatment of Adolescents with Moderate to Severe Plaque Psoriasis
Sep 26, 2016Approval FDA Approves Stelara (ustekinumab) for Treatment of Adults with Moderately to Severely Active Crohn's Disease
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

See also

Stelara (ustekinumab) Consumer information

Further information

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