New Drug Approvals Archive - March 2015

Opdivo (nivolumab)

New Indication Approved: March 4, 2015

• FDA Expands Approved use of Opdivo (nivolumab) to Treat Lung Cancer
• Opdivo (nivolumab) FDA Approval History

Elepsia XR (levetiracetam) Extended-Release Tablets

Date of Approval: March 2, 2015
Company: Sun Pharma Advanced Research Company Ltd.
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.

• SPARC Announces FDA Approval of Elepsia XR (levetiracetam) Extended-Release Tablets
• Elepsia XR (levetiracetam) FDA Approval History

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.

• FDA Approves First Biosimilar Product Zarxio (filgrastim-sndz)
• Zarxio (filgrastim-sndz) FDA Approval History

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.

• FDA Approves Cresemba (isavuconazonium sulfate) For Fungal Infections
• Cresemba (isavuconazonium) FDA Approval History

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.

• FDA Approves Unituxin (dinutuximab) for Pediatric High-Risk Neuroblastoma
• Unituxin (dinutuximab) FDA Approval History

Saphris (asenapine)

Patient Population Altered: March 13, 2015

• Actavis Receives FDA Approval of Saphris for Pediatric Patients with Bipolar I Disorder
• Saphris (asenapine) FDA Approval History

Viibryd (vilazodone)

New Dosage Regimen: March 16, 2015

• Actavis Receives FDA Approval for Viibryd (vilazodone HCl) 20mg Once Daily as a Therapeutic Dose
• Viibryd (vilazodone) FDA Approval History

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).

• FDA Approves Cholbam (cholic acid) for Rare Bile Acid Synthesis Disorders
• Cholbam (cholic acid) FDA Approval History

Kalydeco (ivacaftor)

New Dosage Form Approved: March 17, 2015

• FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 2 to 5 with CFTR Gene Mutations
• Kalydeco (ivacaftor) FDA Approval History

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.

• FDA Approves Anthrasil, [Anthrax Immune Globulin Intravenous (Human)], for Inhalation Anthrax
• Anthrasil (Anthrax Immune Globulin Intravenous (Human)) FDA Approval History

Eylea (aflibercept)

New Indication Approved: March 25, 2015
Treatment for: Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetic Macular Edema

• FDA Approves Eylea (aflibercept) for Diabetic Retinopathy in Patients with Diabetic Macular Edema
• Eylea (aflibercept) FDA Approval History

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.

• Sanofi Pasteur Announces FDA Approval of Quadracel DTaP-IPV Vaccine for Children 4 through 6 Years of Age
• Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV Vaccine) FDA Approval History

Brilinta (ticagrelor)

Labeling Revision Approved: March 26, 2015

• FDA Approves New Crushing Option for the Administration of Brilinta
• Brilinta (ticagrelor) FDA Approval History

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.

• FDA Approves Jadenu (deferasirox) Tablets for Chronic Iron Overload
• Jadenu (deferasirox) FDA Approval History

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.

• Teva Announces FDA Approval of ProAir RespiClick
• ProAir RespiClick (albuterol sulfate) FDA Approval History

ProAir RespiClick (albuterol sulfate)

Patient Population Altered: April 29, 2016

• Teva Announces FDA Approval of ProAir RespiClick (albuterol sulfate) Inhalation Powder for Pediatric Asthma Patients Ages 4 to 11
• ProAir RespiClick (albuterol sulfate) FDA Approval History