New Drug Approvals Archive

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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

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.

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

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

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