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New Drug Approvals Archive - December 2002

December 2002

December 2	Lexapro (escitalopram oxalate) New Dosage Form Approved: November 27, 2002 Lexapro Oral Solution Formulation Provides New Option for Depressed Patients
December 18	Lexapro (escitalopram oxalate) New Indication Approved: December 18, 2002 Lexapro Receives FDA Approval for the Treatment of Generalized Anxiety Disorder
December 31	Humira (adalimumab) Injection Date of Approval: December 31, 2002 Company: Abbvie, Inc. Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Crohn's Disease -- Acute, Crohn's Disease -- Maintenance, Psoriasis, Juvenile Idiopathic Arthritis, Ulcerative Colitis, Hidradenitis Suppurativa, Uveitis Humira (adalimumab) is a recombinant human IgGl monoclonal antibody specific for human tumor necrosis factor (TNF) indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, psoriasis, juvenile idiopathic arthritis, ulcerative colitis, hidradenitis suppurativa, and certain types of uveitis. FDA Approves Humira for Rheumatoid Arthritis
October 4	Humira (adalimumab) New Indication Approved: October 3, 2005 Humira Receives FDA Approval for Psoriatic Arthritis
July 31	Humira (adalimumab) New Indication Approved: July 31, 2006 Humira Receives FDA Approval for Treatment of Ankylosing Spondylitis
February 27	Humira (adalimumab) New Indication Approved: February 27, 2007 Humira (Adalimumab) Receives FDA Approval For Treatment of Crohn'sDisease
January 22	Humira (adalimumab) New Indication Approved: January 18, 2008 Abbott's Humira (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis
February 22	Humira (adalimumab) New Indication Approved: February 21, 2008 Abbott Receives FDA Approval for Humira (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis
September 28	Humira (adalimumab) New Indication Approved: September 28, 2012 FDA Approves Humira to Treat Ulcerative Colitis
September 25	Humira (adalimumab) Patient Population Altered: September 23, 2014 FDA Approves Humira (adalimumab) for the Treatment of Pediatric Patients with Crohn's Disease
July 31	Finacea (azelaic acid) New Dosage Form Approved: July 29, 2015 FDA Approves Finacea (azelaic acid) Foam for Rosacea
September 11	Humira (adalimumab) New Indication Approved: September 10, 2015 FDA Approves Humira (adalimumab) for Moderate to Severe Hidradenitis Suppurativa
June 30	Humira (adalimumab) New Indication Approved: June 30, 2016 AbbVie's Humira (adalimumab) Receives FDA Approval to Treat Adults with Non-Infectious Intermediate, Posterior and Panuveitis
March 30	Humira (adalimumab) Labeling Revision Approved: March 27, 2017 FDA Approves Addition of Moderate to Severe Fingernail Psoriasis Data to AbbVie's Humira (adalimumab) Prescribing Information

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