New Drug Approvals Archive - March 2011
New Dosage Form Approved: March 3, 2011
Benlysta (belimumab) Injection
Date of Approval: March 10, 2011
Benlysta (belimumab) is B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus.
Gadavist (gadobutrol) Injection
Date of Approval: March 14, 2011
Gadavist (gadobutrol) is a gadolinium-based contrast agent indicated for use in diagnostic magnetic resonance imaging (MRI).
Zostavax (zoster vaccine live)
Patient Population Altered: March 24, 2011
New Indication Approved: March 24, 2011
Yervoy (ipilimumab) Injection
Date of Approval: March 25, 2011
Yervoy (ipilimumab) is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for the treatment of unresectable or metastatic melanoma.
New Formulation Approved: March 25, 2011
Sylatron (peginterferon alfa-2b)
Date of Approval: March 29, 2011
Sylatron (peginterferon alfa-2b) is an alpha interferon indicated for the adjuvant treatment of melanoma.
Patient Population Altered: December 29, 2014
New Indication Approved: October 28, 2015
New Indication Approved: April 27, 2016