New Drug Approvals Archive - December 2002

Lexapro (escitalopram oxalate)

New Dosage Form Approved: November 27, 2002

• Lexapro Oral Solution Formulation Provides New Option for Depressed Patients

Lexapro (escitalopram oxalate)

New Indication Approved: December 18, 2002

• Lexapro Receives FDA Approval for the Treatment of Generalized Anxiety Disorder

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

Humira (adalimumab)

New Indication Approved: October 3, 2005

• Humira Receives FDA Approval for Psoriatic Arthritis

Humira (adalimumab)

New Indication Approved: July 31, 2006

• Humira Receives FDA Approval for Treatment of Ankylosing Spondylitis

Humira (adalimumab)

New Indication Approved: February 27, 2007

• Humira (Adalimumab) Receives FDA Approval For Treatment of Crohn'sDisease

Humira (adalimumab)

New Indication Approved: January 18, 2008

• Abbott's Humira (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis

Humira (adalimumab)

New Indication Approved: February 21, 2008

• Abbott Receives FDA Approval for Humira (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis

Humira (adalimumab)

New Indication Approved: September 28, 2012

• FDA Approves Humira to Treat Ulcerative Colitis

Humira (adalimumab)

Patient Population Altered: September 23, 2014

• FDA Approves Humira (adalimumab) for the Treatment of Pediatric Patients with Crohn's Disease

Finacea (azelaic acid)

New Dosage Form Approved: July 29, 2015

• FDA Approves Finacea (azelaic acid) Foam for Rosacea

Humira (adalimumab)

New Indication Approved: September 10, 2015

• FDA Approves Humira (adalimumab) for Moderate to Severe Hidradenitis Suppurativa

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

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