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New Drug Approvals Archive

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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, in combination with chlorambucil for the treatment of patients with previously untreated 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.

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

Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia.

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.

Luzu (luliconazole) FDA Approval History

November 22

Nexavar (sorafenib)

New Indication Approved: November 22, 2013

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)

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.

Olysio (simeprevir) FDA Approval History

November 26

Noxafil (posaconazole)

New Dosage Form Approved: November 25, 2013

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.

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 (sucroferric oxyhydroxide) FDA Approval History

February 12

Imbruvica (ibrutinib)

New Indication Approved: February 12, 2014
Treatment for: Mantle Cell Lymphoma; 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

Imbruvica (ibrutinib) FDA Approval History

November 5

Olysio (simeprevir)

Labeling Revision Approved: November 5, 2014

Olysio (simeprevir) FDA Approval History

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