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New Drug Approvals Archive - March 2016

See also: New Indications and Dosage Forms for March 2016

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.

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.

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.

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.

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.

Taltz (ixekizumab) Injection

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

Taltz (ixekizumab) is a humanized interleukin-17A antagonist indicated for the treatment of:

  • patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
  • adults with active psoriatic arthritis.
  • adults with active ankylosing spondylitis.
  • adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.

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.

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).

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