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Orencia Approval History

FDA Approved: Yes (First approved December 23, 2005)
Brand name: Orencia
Generic name: abatacept
Dosage form: Injection
Company: Bristol-Myers Squibb Company
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis

Orencia (abatacept) is a selective T cell costimulation modulator indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis.

Development History and FDA Approval Process for Orencia

Jul  6, 2017Approval Bristol-Myers Squibb’s Orencia (abatacept) Receives FDA Approval for Treatment of Active Psoriatic Arthritis in Adults
Jun 12, 2013Orencia (Abatacept) Shows Comparable Efficacy to Humira
Jul 31, 2011Approval U.S. Food and Drug Administration Approves Subcutaneous Formulation of Orencia (abatacept), a Proven Non-Anti-TNF Biologic for Adults with Moderate to Severe Rheumatoid Arthritis
Oct 20, 2009ORENCIA (abatacept) Demonstrated Sustained Clinical Response in a Study of Adult Patients with Moderate to Severe Early Rheumatoid Arthritis (Less Than Two Years Duration)
Jun 12, 2009Orencia (Abatacept) Demonstrates Consistent Safety And Effectiveness Over 7 Years
Oct 28, 2008Data Demonstrate Orencia (abatacept) Improves Health-Related Quality of Life, Pain and Sleep Quality in Children With Juvenile Idiopathic Arthritis
Dec 23, 2005Approval Orencia Bristol-Myers Squibb Company - Treatment for Rheumatoid Arthritis
Sep  6, 2005Bristol-Myers Squibb Statement on FDA Advisory Committee Vote on Orencia (Abatacept), an Investigational Selective Modulator of T-Cell Co-Stimulation for Rheumatoid Arthritis
Dec 23, 2004Bristol-Myers Squibb Provides Regulatory Update for Abatacept

Further information

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