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Otezla FDA Approval History

Last updated by Judith Stewart, BPharm on July 20, 2019.

FDA Approved: Yes (First approved March 21, 2014)
Brand name: Otezla
Generic name: apremilast
Dosage form: Tablets
Company: Celgene Corporation
Treatment for: Psoriatic Arthritis, Plaque Psoriasis, Behcet's Disease

Otezla (apremilast) is a phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of psoriatic arthritis, plaque psoriasis, and oral ulcers associated with Behçet’s Disease.

Development timeline for Otezla

Sep  8, 2022Amgen Announces Positive New Data for Otezla
Dec 20, 2021Approval FDA Approves Otezla (apremilast) for the Treatment of Adult Patients with Plaque Psoriasis, Regardless of Severity Level
Jul 19, 2019Approval FDA Approves Otezla (apremilast) for the Treatment of Oral Ulcers Associated with Behçet’s Disease
Sep 23, 2014Approval FDA Approves Otezla (apremilast) for Moderate to Severe Plaque Psoriasis
Mar 21, 2014Approval FDA Approves Otezla (apremilast) to Treat Psoriatic Arthritis

Further information

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