New Drug Approvals Archive - January 2010

Velcade (bortezomib)

Labeling Revision Approved: December 30, 2009

FDA Approves Addition of Sustained Overall Survival Benefit to Label for Velcade (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma

Actemra (tocilizumab) Injection

Date of Approval: January 8, 2010
Company: Genentech USA, Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Giant Cell Arteritis

Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment rheumatoid arthritis; systemic juvenile idiopathic arthritis (SJIA); polyarticular juvenile idiopathic arthritis (PJIA); giant cell arteritis; and CAR T cell-induced severe or life-threatening cytokine release syndrome.

FDA Approves Actemra for the Treatment of Moderately to Severely Active Rheumatoid Arthritis

Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate)

Labeling Revision Approved: January 7, 2010

HIV/AIDS Update - Atripla label update reflects new efficacy, safety and resistance data in treatment experienced patients

Ampyra (dalfampridine) Extended Release Tablets - formerly Fampridine-SR

Date of Approval: January 22, 2010
Company: Acorda Therapeutics, Inc.
Treatment for: Multiple Sclerosis

Ampyra (dalfampridine) is an oral potassium channel blocker indicated to improve walking ability in people with multiple sclerosis.

FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis

Victoza (liraglutide) Injection

Date of Approval: January 25, 2010
Company: Novo Nordisk A/S
Treatment for: Diabetes Type 2

Victoza (liraglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults with type 2 diabetes mellitus, and to reduce the risk of heart attack, stroke and CV death in adults with type 2 diabetes and established CV disease.

FDA Approves Novo-Nordisk's Diabetes Drug Victoza

Prezista (darunavir)

Labeling Revision Approved: January 27, 2010

U.S. Food and Drug Administration Approves Labeling Update for Prezista To Include 96-Week Data in HIV-1 Infected Adult Patients

Actemra (tocilizumab)

Labeling Revision Approved: January 4, 2011

FDA Grants Supplemental Approval for Actemra (tocilizumab)

Actemra (tocilizumab)

New Indication Approved: April 15, 2011

FDA Approves Actemra (tocilizumab) for the Treatment of Systemic Juvenile Idiopathic Arthritis (SJIA)

Victoza (liraglutide)

Labeling Revision Approved: April 6, 2012

Victoza Label Updated to Include Data Showing Superior Efficacy When Compared to Januvia

Actemra (tocilizumab)

New Indication Approved: April 30, 2013

FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis

Actemra (tocilizumab)

New Formulation Approved: October 21, 2013

Genentech Gains FDA Approval for New Subcutaneous Formulation of Actemra for use in Adult Patients Living with Moderately to Severely Active Rheumatoid Arthritis

Actemra (tocilizumab)

New Indication Approved: May 22, 2017

FDA Approves Actemra (tocilizumab) Subcutaneous Injection for Giant Cell Arteritis

Victoza (liraglutide)

New Indication Approved: August 25, 2017

Victoza (liraglutide) is Approved to Reduce the Risk of Three Major Adverse Cardiovascular Events in Type 2 Diabetes Patients

Actemra (tocilizumab)

New Indication Approved: August 30, 2017

FDA Approves Genentech’s Actemra (tocilizumab) for the Treatment of CAR T Cell-Induced Cytokine Release Syndrome

Actemra (tocilizumab)

New Dosage Regimen: May 11, 2018

FDA Approves Subcutaneous Formulation of Actemra for use in Active Polyarticular Juvenile Idiopathic Arthritis