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
• Actemra (tocilizumab) FDA Approval History

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
• Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) FDA Approval History

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
• Ampyra (dalfampridine) FDA Approval History

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
• Victoza (liraglutide) FDA Approval History

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
• Prezista (darunavir) FDA Approval History

Actemra (tocilizumab)

Labeling Revision Approved: January 4, 2011

• FDA Grants Supplemental Approval for Actemra (tocilizumab)
• Actemra (tocilizumab) FDA Approval History

Actemra (tocilizumab)

New Indication Approved: April 15, 2011

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

Victoza (liraglutide)

Labeling Revision Approved: April 6, 2012

• Victoza Label Updated to Include Data Showing Superior Efficacy When Compared to Januvia
• Victoza (liraglutide) FDA Approval History

Actemra (tocilizumab)

New Indication Approved: April 30, 2013

• FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis
• Actemra (tocilizumab) FDA Approval History

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) FDA Approval History

Actemra (tocilizumab)

New Indication Approved: May 22, 2017

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

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
• Victoza (liraglutide) FDA Approval History

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) FDA Approval History

Actemra (tocilizumab)

New Dosage Regimen: May 11, 2018

• FDA Approves Subcutaneous Formulation of Actemra for use in Active Polyarticular Juvenile Idiopathic Arthritis
• Actemra (tocilizumab) FDA Approval History