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
|Aug 1, 2022||Approval Stelara (ustekinumab) Approved by the U.S. Food and Drug Administration to Treat Pediatric Patients with Active Psoriatic Arthritis|
|Jul 30, 2020||Approval FDA Approves Stelara (ustekinumab) for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis|
|Oct 21, 2019||Approval Janssen Announces FDA Approval of Stelara (ustekinumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis|
|Oct 13, 2017||Approval Janssen Announces FDA Approval of Stelara (ustekinumab) for the Treatment of Adolescents with Moderate to Severe Plaque Psoriasis|
|Sep 26, 2016||Approval FDA Approves Stelara (ustekinumab) for Treatment of Adults with Moderately to Severely Active Crohn's Disease|
|Sep 23, 2013||Approval Stelara (ustekinumab) Receives FDA Approval to Treat Active Psoriatic Arthritis|
|Sep 25, 2009||Approval 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|
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