New Drug Approvals Archive - March 2016

Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide) Tablets

Date of Approval: March 1, 2016
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide) is a fixed-dose combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and rilpivirine (RPV), a non-nucleoside reverse transcriptase inhibitor (NNRTI), indicated as a complete regimen for the treatment of HIV-1 infection.

• FDA Approves Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide) for the Treatment of HIV-1 Infection

Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide) FDA Approval History

Idelvion (coagulation factor IX (recombinant), albumin fusion protein) Injection

Date of Approval: March 4, 2016
Company: CSL Behring
Treatment for: Hemophilia B

Idelvion (coagulation factor IX (recombinant), albumin fusion protein) is a long-acting recombinant human blood coagulation factor indicated for the control and prevention of bleeding episodes in patients with hemophilia B.

• FDA Approves Idelvion (coagulation factor IX (recombinant), albumin fusion protein) to Treat Patients with Hemophilia B

Idelvion (coagulation factor IX (recombinant), albumin fusion protein) 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

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

Imbruvica (ibrutinib) FDA Approval History

Xalkori (crizotinib)

New Indication Approved: March 11, 2016

• FDA Expands Use of Xalkori (crizotinib) to Treat ROS-1 Positive Non-Small Cell Lung Cancer

Xalkori (crizotinib) FDA Approval History

Evomela (melphalan) for Injection

Date of Approval: March 10, 2016
Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Multiple Myeloma

Evomela (melphalan) is an alkylating agent used as a high-dose conditioning treatment prior to stem cell transplantation in patients with multiple myeloma (MM), and for the palliative treatment of patients with MM for whom oral therapy is not appropriate.

• FDA Grants Spectrum Pharmaceuticals Approval of Evomela (melphalan) for Injection

Evomela (melphalan) FDA Approval History

Kovaltry (antihemophilic factor (recombinant)) Injection

Date of Approval: March 16, 2016
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Hemophilia A

Kovaltry (antihemophilic factor (recombinant)) is a human DNA sequence derived, full length Factor VIII concentrate indicated for the control and prevention of bleeding episodes in adults and children with hemophilia A.

• FDA Approves Bayer's Kovaltry (Antihemophilic Factor (Recombinant)) for the Treatment of Children and Adults with Hemophilia A

Kovaltry (antihemophilic factor (recombinant)) FDA Approval History

Anthim (obiltoxaximab) Injection

Date of Approval: March 18, 2016
Company: Elusys Therapeutics, Inc.
Treatment for: Anthrax Prophylaxis, Inhalation Bacillus anthracis

Anthim (obiltoxaximab) is a monoclonal antibody (mAb) anthrax antitoxin for the treatment and prevention of inhalational anthrax.

• FDA Approves Anthim (obiltoxaximab) for Inhalation Anthrax

Anthim (obiltoxaximab) FDA Approval History

Taltz (ixekizumab) Injection

Date of Approval: March 22, 2016
Company: Eli Lilly and Company
Treatment for: Plaque Psoriasis

Taltz (ixekizumab) is a humanized interleukin-17A antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis.

• FDA Approves Taltz (ixekizumab) for Plaque Psoriasis

Taltz (ixekizumab) FDA Approval History

Cinqair (reslizumab) Injection

Date of Approval: March 23, 2016
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Asthma

Cinqair (reslizumab) is an interleukin 5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with eosinophilic asthma.

• FDA Approves Cinqair (reslizumab) to Treat Severe Asthma

Cinqair (reslizumab) FDA Approval History

Defitelio (defibrotide) Injection

Date of Approval: March 30, 2016
Company: Jazz Pharmaceuticals plc
Treatment for: Hepatic Veno-Occlusive Disease

Defitelio (defibrotide sodium) is a deoxyribonucleic acid derivative anticoagulant for the treatment of patients with hepatic veno-occlusive disease (VOD) with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).

• FDA Approves Defitelio (defibrotide sodium) for Hepatic Veno-Occlusive Disease Following Hematopoietic Stem-Cell Transplantation

Defitelio (defibrotide) FDA Approval History