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New Drug Approvals Archive - January 2010

January 2010

January 5

Velcade (bortezomib)

Labeling Revision Approved: December 30, 2009

January 8

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.

Actemra (tocilizumab) FDA Approval History

January 11

Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate)

Labeling Revision Approved: January 7, 2010

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

January 22

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.

Ampyra (dalfampridine) FDA Approval History

January 25

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.

Victoza (liraglutide) FDA Approval History

January 28

Prezista (darunavir)

Labeling Revision Approved: January 27, 2010

Prezista (darunavir) FDA Approval History

January 5

Actemra (tocilizumab)

Labeling Revision Approved: January 4, 2011

Actemra (tocilizumab) FDA Approval History

April 17

Actemra (tocilizumab)

New Indication Approved: April 15, 2011

Actemra (tocilizumab) FDA Approval History

April 9

Victoza (liraglutide)

Labeling Revision Approved: April 6, 2012

Victoza (liraglutide) FDA Approval History

April 30

Actemra (tocilizumab)

New Indication Approved: April 30, 2013

Actemra (tocilizumab) FDA Approval History

October 22

Actemra (tocilizumab)

New Formulation Approved: October 21, 2013

Actemra (tocilizumab) FDA Approval History

May 22

Actemra (tocilizumab)

New Indication Approved: May 22, 2017

Actemra (tocilizumab) FDA Approval History

August 25

Victoza (liraglutide)

New Indication Approved: August 25, 2017

Victoza (liraglutide) FDA Approval History

August 31

Actemra (tocilizumab)

New Indication Approved: August 30, 2017

Actemra (tocilizumab) FDA Approval History

New Drug Approvals Archive