New Drug Approvals Archive - November 2013

Gazyva (obinutuzumab) Injection

Date of Approval: November 1, 2013
Company: Genentech
Treatment for: Chronic Lymphocytic Leukemia, Follicular Lymphoma

Gazyva (obinutuzumab) is a CD20-directed cytolytic antibody indicated for the combination treatment of patients with chronic lymphocytic leukemia and follicular lymphoma.

• FDA Approves Gazyva for Chronic Lymphocytic Leukemia
• 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.

• FDA Approves Aptiom to Treat Seizures in Adults
• Aptiom (eslicarbazepine acetate) FDA Approval History

Imbruvica (ibrutinib) Capsules and Tablets

Date of Approval: November 13, 2013
Company: AbbVie Inc.
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 indicated for the treatment of adult patients with:

• Mantle cell lymphoma (MCL) who have received at least one prior therapy.
  Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)
• Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.
• Waldenström’s macroglobulinemia (WM).
• Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
  Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.

• FDA Approves Imbruvica (ibrutinib) for Mantle Cell Lymphoma
• 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.

• Valeant Pharmaceuticals Announces U.S. Approval Of Luzu Cream, 1%
• Luzu (luliconazole) FDA Approval History

Olysio (simeprevir) Capsules

Date of Approval: November 22, 2013
Company: Janssen Research & Development, LLC
Treatment for: 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

Varithena (polidocanol) Injectable Foam

Date of Approval: November 25, 2013
Company: BTG plc
Treatment for: Varicose Veins

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

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