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New Drug Approvals Archive - November 2013

November 2013

November 1	Gazyva (obinutuzumab) Injection Date of Approval: November 1, 2013 Company: Genentech Treatment for: Chronic Lymphocytic Leukemia Gazyva (obinutuzumab) is a CD20-directed cytolytic antibody indicated for the combination treatment of patients with previously untreated chronic lymphocytic leukemia and follicular lymphoma. FDA Approves Gazyva for Chronic Lymphocytic Leukemia Gazyva (obinutuzumab) FDA Approval History
November 8	Aptiom (eslicarbazepine acetate) Tablets - formerly Stedesa Date of Approval: November 8, 2013 Company: Sunovion Pharmaceuticals Inc. Treatment for: Epilepsy, Seizures Aptiom (eslicarbazepine acetate) is a voltage-gated sodium channel blocker for the treatment of partial-onset seizures in adults with epilepsy. FDA Approves Aptiom to Treat Seizures in Adults Aptiom (eslicarbazepine acetate) FDA Approval History
November 13	Imbruvica (ibrutinib) Capsules Date of Approval: November 13, 2013 Company: Janssen Research & Development, LLC Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenström’s Macroglobulinemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma, chronic lymphocytic leukemia, Waldenström’s macroglobulinemia, small lymphocytic lymphoma, and marginal zone lymphoma. FDA Approves Imbruvica (ibrutinib) for Mantle Cell Lymphoma Imbruvica (ibrutinib) FDA Approval History
November 14	Luzu (luliconazole) Topical Cream Date of Approval: November 14, 2013 Company: Valeant Pharmaceuticals International, Inc. Treatment for: Tinea Corporis, Tinea Pedis, Tinea Cruris Luzu (luliconazole) Cream is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis. Valeant Pharmaceuticals Announces U.S. Approval Of Luzu Cream, 1% Luzu (luliconazole) FDA Approval History
November 22	Nexavar (sorafenib) New Indication Approved: November 22, 2013 FDA Approves Nexavar to Treat Metastatic Differentiated Thyroid Cancer Nexavar (sorafenib) FDA Approval History
November 22	Influenza Virus Vaccine, H5N1 () New Formulation Approved: November 22, 2013 Treatment for: Prevention of H5N1 Influenza (Avian Influenza) FDA Approves First Adjuvanted Vaccine for Prevention of H5N1 Avian Influenza Influenza Virus Vaccine, H5N1 FDA Approval History
November 22	Olysio (simeprevir) Capsules Date of Approval: November 22, 2013 Company: Janssen Research & Development, LLC Treatment for: Chronic Hepatitis C Olysio (simeprevir) is a protease inhibitor for the treatment of chronic hepatitis C virus infection. FDA Approves Olysio (simeprevir) for Hepatitis C Virus Olysio (simeprevir) FDA Approval History
November 26	Noxafil (posaconazole) New Dosage Form Approved: November 25, 2013 FDA Approves Merck’s Noxafil Delayed-Release Tablets Noxafil (posaconazole) FDA Approval History
November 25	Varithena (polidocanol) Injectable Foam Date of Approval: November 25, 2013 Company: BTG plc Treatment for: Varicose Vein Varithena (polidocanol) injectable foam is a sclerosing agent indicated for the treatment of varicose veins. FDA Approves Varithena (Polidocanol Injectable Foam) for the Treatment of Patients with Varicose Veins Varithena (polidocanol) FDA Approval History
November 27	Velphoro (sucroferric oxyhydroxide) Chewable Tablets Date of Approval: November 27, 2013 Company: Vifor Fresenius Medical Care Renal Pharma Treatment for: Hyperphosphatemia of Renal Failure 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. Velphoro Receives US FDA Approval for the Treatment of Hyperphosphatemia in Chronic Kidney Disease Patients on Dialysis Velphoro (sucroferric oxyhydroxide) FDA Approval History
February 12	Imbruvica (ibrutinib) New Indication Approved: February 12, 2014 Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenström’s Macroglobulinemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma FDA Approves Imbruvica (ibrutinib) to Treat Chronic Lymphocytic Leukemia Imbruvica (ibrutinib) FDA Approval History
July 28	Imbruvica (ibrutinib) New Indication Approved: July 28, 2014 Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenström’s Macroglobulinemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma FDA Expands Approved Use of Imbruvica (ibrutinib) for Chronic Lymphocytic Leukemia Imbruvica (ibrutinib) FDA Approval History
November 5	Olysio (simeprevir) Labeling Revision Approved: November 5, 2014 FDA Approves Olysio (simeprevir) in Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C Infection Olysio (simeprevir) FDA Approval History
January 29	Imbruvica (ibrutinib) New Indication Approved: January 29, 2015 Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenström’s Macroglobulinemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma FDA Expands Approved Use of Imbruvica (ibrutinib) for Waldenström’s Macroglobulinemia Imbruvica (ibrutinib) FDA Approval History
August 28	Aptiom (eslicarbazepine acetate) New Indication Approved: August 27, 2015 FDA Approves New Indication for Aptiom (eslicarbazepine acetate) as Monotherapy for Partial-Onset Seizures Aptiom (eslicarbazepine acetate) FDA Approval History
February 26	Gazyva (obinutuzumab) New Indication Approved: February 26, 2016 FDA Approves Genentech’s Gazyva (obinutuzumab) for Certain People with Previously Treated Follicular Lymphoma Gazyva (obinutuzumab) FDA Approval History
March 4	Imbruvica (ibrutinib) New Indication Approved: March 4, 2016 Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenström’s Macroglobulinemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma FDA Approves Imbruvica (ibrutinib) for the First-Line Treatment of Chronic Lymphocytic Leukemia Imbruvica (ibrutinib) FDA Approval History
May 9	Imbruvica (ibrutinib) New Indication Approved: May 6, 2016 Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenström’s Macroglobulinemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma U.S. FDA Expands Imbruvica (ibrutinib) Label to Include Overall Survival Data in Previously Untreated Chronic Lymphocytic Leukemia (CLL) and New Indication for Small Lymphocytic Lymphoma (SLL) Patients Imbruvica (ibrutinib) FDA Approval History
January 19	Imbruvica (ibrutinib) New Indication Approved: January 18, 2017 Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenström’s Macroglobulinemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma U.S. FDA Approves Imbruvica (ibrutinib) as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Zone Lymphoma (MZL) Imbruvica (ibrutinib) FDA Approval History

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