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

Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment of moderate to severe rheumatoid arthritis in adults, and the treatment of active systemic juvenile idiopathic arthritis (SJIA) and polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older.

• 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 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

• 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