New Drug Approvals Archive - March 2015

March 2015

Elepsia XR (levetiracetam) Extended-Release Tablets

Date of Approval: March 2, 2015
Company: Sun Pharma Global
Treatment for: Epilepsy

Elepsia XR (levetiracetam) is an extended-release formulation of the antiepileptic drug levetiracetam designed to reduce pill burden in patients receiving high doses for the treatment of partial onset seizures.

Zarxio (filgrastim-sndz) Injection

Date of Approval: March 6, 2015
Company: Sandoz
Treatment for: Neutropenia Associated with Chemotherapy

Zarxio (filgrastim-sndz) is a leukocyte growth factor biosimilar to the reference product Neupogen, indicated for the treatment of neutropenia associated with chemotherapy.

Cresemba (isavuconazonium) Capsules and Injection

Date of Approval: March 6, 2015
Company: Astellas Pharma US, Inc.
Treatment for: Invasive Aspergillosis; Invasive Mucormycosis

Cresemba (isavuconazonium) is an azole antifungal indicated for the treatment of invasive aspergillosis and invasive mucormycosis.

Unituxin (dinutuximab) Injection

Date of Approval: March 10, 2015
Company: United Therapeutics Corporation
Treatment for: Neuroblastoma

Unituxin (dinutuximab) is a chimeric monoclonal antibody used for the treatment of pediatric neuroblastoma.

Cholbam (cholic acid) Capsules

Date of Approval: March 17, 2015
Company: Asklepion Pharmaceuticals LLC
Treatment for: Bile Acid Synthesis Disorders

Cholbam (cholic acid) is a bile acid preparation for the treatment of patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders).

Anthrasil (Anthrax Immune Globulin Intravenous (Human)) Injection

Date of Approval: March 24, 2015
Company: Cangene Corporation
Treatment for: Inhalation Anthrax

Anthrasil [Anthrax Immune Globulin Intravenous (Human)] is an immune globulin used to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.

Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV Vaccine) Injection

Date of Approval: March 24, 2015
Company: Sanofi Pasteur
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Poliomyelitis Prophylaxis, Pertussis Prophylaxis

Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV) is a vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children 4 through 6 years of age.

Jadenu (deferasirox) Tablets

Date of Approval: March 30, 2015
Company: Novartis Pharmaceuticals Corporation
Treatment for: Iron Overload

Jadenu (deferasirox) is a tablet formulation of Exjade, an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older.

ProAir RespiClick (albuterol sulfate) Inhalation Powder

Date of Approval: March 31, 2015
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Asthma

ProAir RespiClick (albuterol sulfate) is a breath-actuated, dry-powder, short-acting beta-agonist (SABA) inhaler for the relief of acute asthma symptoms.