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New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic Approvals, Approval Process, New Indications and Dosage forms

Viberzi (eluxadoline)

Company: Actavis plc
Date of Approval: May 27, 2015
Treatment for: Irritable Bowel Syndrome

Viberzi (eluxadoline) is a mu-opioid receptor agonist indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

Viberzi FDA Approval History

Stiolto Respimat (olodaterol and tiotropium) Inhalation Spray

Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Date of Approval: May 21, 2015
Treatment for: Chronic Obstructive Pulmonary Disease

Stiolto Respimat (olodaterol and tiotropium bromide) is a long-acting beta agonist (LABA) and long-acting muscarinic antagonist (LAMA) fixed-dose combination for the treatment of chronic obstructive pulmonary disease (COPD).

Stiolto Respimat FDA Approval History

Invega Trinza (paliperidone palmitate) Extended-Release Injectable Suspension

Company: Janssen Pharmaceuticals, Inc.
Date of Approval: May 18, 2015
Treatment for: Schizophrenia

Invega Trinza (3-month paliperidone palmitate) is a long-acting injectable atypical antipsychotic indicated for the treatment of schizophrenia.

Invega Trinza FDA Approval History

Raplixa (fibrin sealant [human])

Company: ProFibrix BV
Date of Approval: April 30, 2015
Treatment for: Hemostasis

Raplixa (fibrin sealant [human]) is a spray-dried fibrin sealant used to help control bleeding during surgery.

Raplixa FDA Approval History

Tuzistra XR (chlorpheniramine polistirex and codeine polistirex)

Company: Vernalis plc and Tris Pharma Inc.
Date of Approval: April 30, 2015
Treatment for: Cold Symptoms

Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) is an extended-release opiate agonist antitussive and histamine-1 (H1) receptor antagonist combination indicated for the relief of cough and symptoms associated with upper respiratory allergies or the common cold.

Tuzistra XR FDA Approval History

Kybella (deoxycholic acid) Injection - formerly ATX-101

Company: Kythera Biopharmaceuticals, Inc.
Date of Approval: April 29, 2015
Treatment for: Submental Fullness

Kybella (deoxycholic acid) is a cytolytic drug indicated to improve the appearance of fullness associated with submental fat (double chin).

Kybella FDA Approval History

Ixinity (coagulation factor IX (recombinant))

Company: Emergent BioSolutions Inc.
Date of Approval: April 29, 2015
Treatment for: Hemophilia B

Ixinity (coagulation factor IX (recombinant)) is a clotting factor IX therapy indicated to prevent bleeding in patients with hemophilia B.

Ixinity FDA Approval History

Glatopa (glatiramer acetate) Injection

Company: Sandoz Inc.
Date of Approval: April 16, 2015
Treatment for: Multiple Sclerosis

Glatopa (glatiramer acetate) is a generic version of Copaxone, an immunomodulator drug for the treatment of patients with relapsing-forms of multiple sclerosis.

Glatopa FDA Approval History

Corlanor (ivabradine) Tablets

Company: Amgen Inc.
Date of Approval: April 15, 2015
Treatment for: Chronic Heart Failure

Corlanor (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated for the treatment of chronic heart failure.

Corlanor FDA Approval History

ProAir RespiClick (albuterol sulfate) Inhalation Powder

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

ProAir RespiClick FDA Approval History

Jadenu (deferasirox) Tablets

Company: Novartis Pharmaceuticals Corporation
Date of Approval: March 30, 2015
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.

Jadenu FDA Approval History

Anthrasil (Anthrax Immune Globulin Intravenous (Human)) Injection

Company: Cangene Corporation
Date of Approval: March 24, 2015
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.

Anthrasil FDA Approval History

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

Company: Sanofi Pasteur
Date of Approval: March 24, 2015
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.

Quadracel FDA Approval History

Cholbam (cholic acid) Capsules

Company: Asklepion Pharmaceuticals LLC
Date of Approval: March 17, 2015
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).

Cholbam FDA Approval History

Unituxin (dinutuximab) Injection

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

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

Unituxin FDA Approval History

Zarxio (filgrastim-sndz) Injection

Company: Sandoz
Date of Approval: March 6, 2015
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.

Zarxio FDA Approval History

Cresemba (isavuconazonium) Capsules and Injection

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

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

Cresemba FDA Approval History

Elepsia XR (levetiracetam) Extended-Release Tablets

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

Elepsia XR FDA Approval History

Liletta (levonorgestrel) Intrauterine Device - formerly Levosert

Company: Medicines360 and Actavis plc
Date of Approval: February 26, 2015
Treatment for: Contraception

Liletta (levonorgestrel) is a hormonal intrauterine device (IUD) for use by women to prevent pregnancy for up to three years.

Liletta FDA Approval History

Toujeo (insulin glargine [rDNA origin]) Injection

Company: Sanofi
Date of Approval: February 25, 2015
Treatment for: Diabetes Type 1, Diabetes Type 2

Toujeo (insulin glargine [rDNA origin] is a once-daily long-acting basal insulin used to improve glycemic control in adults with type 1 and type 2 diabetes.

Toujeo FDA Approval History
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