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: 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.

• 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

Nexavar (sorafenib)

New Indication Approved: November 22, 2013

• FDA Approves Nexavar to Treat Metastatic Differentiated Thyroid Cancer
• Nexavar (sorafenib) FDA Approval History

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

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

Noxafil (posaconazole)

New Dosage Form Approved: November 25, 2013

• FDA Approves Merck’s Noxafil Delayed-Release Tablets
• 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.

• 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

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

• FDA Approves Imbruvica (ibrutinib) to Treat Chronic Lymphocytic Leukemia
• 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

• FDA Expands Approved Use of Imbruvica (ibrutinib) for Chronic Lymphocytic Leukemia
• Imbruvica (ibrutinib) FDA Approval History

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

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

• FDA Expands Approved Use of Imbruvica (ibrutinib) for Waldenström’s Macroglobulinemia
• Imbruvica (ibrutinib) FDA Approval History

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

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

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

• FDA Approves Imbruvica (ibrutinib) for the First-Line Treatment of Chronic Lymphocytic Leukemia
• 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

• 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

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

• U.S. FDA Approves Imbruvica (ibrutinib) as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Zone Lymphoma (MZL)
• 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

• FDA Approves Imbruvica (ibrutinib) for Chronic Graft Versus Host Disease
• Imbruvica (ibrutinib) FDA Approval History

Aptiom (eslicarbazepine acetate)

Patient Population Altered: September 13, 2017

• Sunovion’s Aptiom (eslicarbazepine acetate) Receives FDA Approval for Expanded Indication to Treat Partial-Onset Seizures in Children and Adolescents 4 Years of Age and Older
• Aptiom (eslicarbazepine acetate) FDA Approval History

Gazyva (obinutuzumab)

New Indication Approved: November 16, 2017

• FDA Approves Genentech’s Gazyva for Previously Untreated Advanced Follicular Lymphoma
• Gazyva (obinutuzumab) FDA Approval History

Luzu (luliconazole)

Patient Population Altered: February 20, 2018

• FDA Approves Expanded Use of Luzu (luliconazole) Cream in Pediatric Patients with Athlete’s Foot, Jock Itch and Ringworm
• Luzu (luliconazole) FDA Approval History