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New Drug Approvals Archive - November 2013

November 2013

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.

Read more: Gazyva (obinutuzumab) FDA Approval History

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 patients with epilepsy.

Read more: Aptiom (eslicarbazepine acetate) FDA Approval History

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; Chronic Graft Versus Host Disease

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, marginal zone lymphoma, and chronic graft versus host disease.

Read more: Imbruvica (ibrutinib) FDA Approval History

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.

Read more: Luzu (luliconazole) FDA Approval History

Influenza Virus Vaccine, H5N1 ()

New Formulation Approved: November 22, 2013
Treatment for: Prevention of H5N1 Influenza (Avian Influenza)

Read more: Influenza Virus Vaccine, H5N1 FDA Approval History

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.

Read more: Olysio (simeprevir) FDA Approval History

Noxafil (posaconazole)

New Dosage Form Approved: November 25, 2013

Read more: Noxafil (posaconazole) FDA Approval History

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.

Read more: Varithena (polidocanol) FDA Approval History

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.

Read more: Velphoro (sucroferric oxyhydroxide) FDA Approval History

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; Chronic Graft Versus Host Disease

Read more: Imbruvica (ibrutinib) FDA Approval History

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; Chronic Graft Versus Host Disease

Read more: Imbruvica (ibrutinib) FDA Approval History

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; Chronic Graft Versus Host Disease

Read more: Imbruvica (ibrutinib) FDA Approval History

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; Chronic Graft Versus Host Disease

Read more: Imbruvica (ibrutinib) FDA Approval History

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; Chronic Graft Versus Host Disease

Read more: Imbruvica (ibrutinib) FDA Approval History

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; Chronic Graft Versus Host Disease

Read more: Imbruvica (ibrutinib) FDA Approval History

Imbruvica (ibrutinib)

New Indication Approved: August 1, 2017
Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenström’s Macroglobulinemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma; Chronic Graft Versus Host Disease

Read more: Imbruvica (ibrutinib) FDA Approval History

New Drug Approvals Archive