New Drug Approvals Archive - November 2013
Gazyva (obinutuzumab) Injection
Date of Approval: November 1, 2013
Gazyva (obinutuzumab) is a CD20-directed cytolytic antibody indicated, in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia.
Aptiom (eslicarbazepine acetate) Tablets - formerly Stedesa
Date of Approval: November 8, 2013
Aptiom (eslicarbazepine acetate) is a voltage-gated sodium channel blocker for the treatment of partial-onset seizures in adults with epilepsy.
Imbruvica (ibrutinib) Capsules
Date of Approval: November 13, 2013
Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma, chronic lymphocytic leukemia, and Waldenström’s macroglobulinemia.
Luzu (luliconazole) Topical Cream
Date of Approval: November 14, 2013
Luzu (luliconazole) Cream is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis.
New Indication Approved: November 22, 2013
New Formulation Approved: November 22, 2013
Olysio (simeprevir) Capsules
Date of Approval: November 22, 2013
Olysio (simeprevir) is a protease inhibitor for the treatment of chronic hepatitis C virus infection.
New Dosage Form Approved: November 25, 2013
Varithena (polidocanol) Injectable Foam
Date of Approval: November 25, 2013
Varithena (polidocanol) injectable foam is a sclerosing agent indicated for the treatment of varicose veins.
Velphoro (sucroferric oxyhydroxide) Chewable Tablets
Date of Approval: November 27, 2013
Velphoro (sucroferric oxyhydroxide) is a chewable, iron-based phosphate binder for the control of serum phosphorus levels in patients with Chronic Kidney Disease (CKD) on dialysis.
New Indication Approved: February 12, 2014
New Indication Approved: July 28, 2014
Labeling Revision Approved: November 5, 2014
New Indication Approved: January 29, 2015