New Drug Approvals Archive - January 2010
Labeling Revision Approved: December 30, 2009
Actemra (tocilizumab) Injection
Date of Approval: January 8, 2010
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.
Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate)
Labeling Revision Approved: January 7, 2010
Ampyra (dalfampridine) Extended Release Tablets - formerly Fampridine-SR
Date of Approval: January 22, 2010
Ampyra (dalfampridine) is an oral potassium channel blocker indicated to improve walking ability in people with multiple sclerosis.
Victoza (liraglutide) Injection
Date of Approval: January 25, 2010
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.
Labeling Revision Approved: January 27, 2010
Labeling Revision Approved: January 4, 2011
New Indication Approved: April 15, 2011
Labeling Revision Approved: April 6, 2012
New Indication Approved: April 30, 2013
New Formulation Approved: October 21, 2013