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GENENTECH (ROCHE): GAZYVA (obinutuzumab) is a CD20-directed cytolytic antibody and is indicated, in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia. PHARMACYCLICS: IMBRUVICA (ibrutinib) is a kinase inhibitor indicated for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is based on overall response rate. An improvement in survival or disease-related symptoms has not been established. JANSSEN (J&J): OLYSIO (simeprevir) is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. SUNOVION PHARMS INC: APTIOM (eslicarbazepine acetate) is indicated as adjunctive treatment of partial-onset seizures. MEDICIS: LUZU (luliconazole) Cream, 1% is an azole antifungal indicated for the topical treat ment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older. New dosage form for NOXAFIL (from MERCK SHARP DOHME ) was approved. New formulation or new manufacturer for VARITHENA (from PROVENSIS LTD), and VELPHORO (from VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA FRANCE) were approved.
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PharmaSages_Nov. FDA ApprovalsGENENTECH (ROCHE): GAZYVA (obinutuzumab) is a CD20-directed cytolytic antibody and is indicated, in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia.
PHARMACYCLICS: IMBRUVICA (ibrutinib) is a kinase inhibitor indicated for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is based on overall response rate. An improvement in survival or disease-related symptoms has not been established.
JANSSEN (J&J): OLYSIO (simeprevir) is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
SUNOVION PHARMS INC: APTIOM (eslicarbazepine acetate) is indicated as adjunctive treatment of partial-onset seizures.
MEDICIS: LUZU (luliconazole) Cream, 1% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older.
New dosage form for NOXAFIL (from MERCK SHARP DOHME ) was approved. New formulation or new manufacturer for
VARITHENA (from PROVENSIS LTD), and VELPHORO (from VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA FRANCE) were approved.
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