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New Drug Approvals Archive for 2015

See also: New Indications and Dosage Forms for 2015

Rytary (carbidopa and levodopa) Extended Release Capsules

Date of Approval: January 7, 2015
Company: Impax Laboratories, Inc.
Treatment for: Parkinson's Disease

Rytary (carbidopa and levodopa) is an extended release aromatic amino acid decarboxylation inhibitor and aromatic amino acid combination indicated for the treatment of Parkinson’s disease.

Savaysa (edoxaban) Tablets

Date of Approval: January 8, 2015
Company: Daiichi Sankyo Company
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism

Savaysa (edoxaban) is an oral, once-daily factor Xa inhibitor anticoagulant indicated for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for the treatment of deep vein thrombosis, and pulmonary embolism.

Duopa (carbidopa and levodopa) Enteral Suspension

Date of Approval: January 12, 2015
Company: AbbVie Inc.
Treatment for: Parkinson's Disease

Duopa (carbidopa and levodopa) is an aromatic amino acid decarboxylation inhibitor and aromatic amino acid combination formulated as an enteral suspension for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.

Phoxillum (renal replacement solution)

Date of Approval: January 13, 2015
Company: Baxter International Inc.
Treatment for: Continuous Renal Replacement Therapy

Phoxillum (renal replacement solution) is a replacement solution used for electrolyte management in Continuous Renal Replacement Therapy (CRRT).

Cosentyx (secukinumab) Injection

Date of Approval: January 21, 2015
Company: Novartis Pharmaceuticals Corporation
Treatment for: Plaque Psoriasis, Ankylosing Spondylitis, Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis

Cosentyx (secukinumab) is a selective interleukin-17A (IL-17A) inhibitor for the treatment of plaque psoriasis, ankylosing spondylitis, psoriatic arthritis, non-radiographic axial spondyloarthritis, and enthesitis-related arthritis.

Prestalia (amlodipine besylate and perindopril arginine) Tablets

Date of Approval: January 21, 2015
Company: Symplmed
Treatment for: High Blood Pressure

Prestalia (amlodipine besylate and perindopril arginine) is a calcium channel blocker and long-acting angiotensin-converting enzyme (ACE) inhibitor combination for the treatment of hypertension.

Natpara (parathyroid hormone) Injection

Date of Approval: January 23, 2015
Company: NPS Pharmaceuticals, Inc.
Treatment for: Hypoparathyroidism

Natpara (parathyroid hormone) is recombinant human parathyroid hormone 1-84 indicated to control hypocalcemia in patients with hypoparathyroidism.

Bexsero (meningococcal group B vaccine) Injection

Date of Approval: January 23, 2015
Company: Novartis Vaccines and Diagnostics Inc.
Treatment for: Meningitis, Meningococcal

Bexsero (meningococcal group B vaccine) is a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.

Triferic (ferric pyrophosphate citrate)

Date of Approval: January 23, 2015
Company: Rockwell Medical, Inc.
Treatment for: Anemia Associated with Chronic Renal Failure

Triferic (ferric pyrophosphate citrate) is an iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis.

Evotaz (atazanavir and cobicistat) Tablets

Date of Approval: January 29, 2015
Company: Bristol-Myers Squibb Company
Treatment for: HIV Infection

Evotaz (atazanavir and cobicistat) is a two-drug combination of atazanavir, a human immunodeficiency virus (HIV-1) protease inhibitor, and cobicistat, a CYP3A inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV‑1infection in adults and pediatric patients weighing at least 35 kg.

Prezcobix (cobicistat and darunavir) Tablets

Date of Approval: January 29, 2015
Company: Janssen Research & Development, LLC
Treatment for: HIV Infection

Prezcobix (darunavir and cobicistat) is a once-daily fixed-dose combination containing a protease inhibitor and a pharmacokinetic enhancer for the treatment of HIV-1 infection.

Pazeo (olopatadine hydrochloride) Ophthalmic Solution

Date of Approval: January 30, 2015
Company: Alcon Laboratories, Inc.
Treatment for: Conjunctivitis, Allergic

Pazeo (olopatadine hydrochloride) is a mast cell stabilizer for the treatment of ocular itching associated with allergic conjunctivitis.

Glyxambi (empagliflozin and linagliptin) Tablets

Date of Approval: January 30, 2015
Company: Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company
Treatment for: Diabetes, Type 2

Glyxambi (empagliflozin and linagliptin) is a sodium glucose co-transporter-2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP-4) inhibitor combination for the treatment of adults with type 2 diabetes.

Ibrance (palbociclib) Capsules and Tablets

Date of Approval: February 3, 2015
Company: Pfizer Inc.
Treatment for: Breast Cancer

Ibrance (palbociclib) is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:

  • an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or
  • fulvestrant in patients with disease progression following endocrine therapy.

Dutrebis (lamivudine and raltegravir) Tablets

Date of Approval: February 6, 2015
Company: Merck
Treatment for: HIV Infection

Dutrebis (lamivudine and raltegravir) is a fixed-dose combination of a nucleoside analog reverse transcriptase inhibitor and an integrase strand transfer inhibitor for the treatment of HIV-1 infection.

Dutrebis is NOT commercially available in the U.S.

Lenvima (lenvatinib) Capsules

Date of Approval: February 13, 2015
Company: Eisai Inc.
Treatment for: Thyroid Cancer, Renal Cell Carcinoma, Hepatocellular Carcinoma, Endometrial Cancer

Lenvima (lenvatinib) is a multiple receptor tyrosine kinase (RTK) inhibitor for the treatment of thyroid cancer, renal cell carcinoma, hepatocellular carcinoma, and endometrial carcinoma.

Farydak (panobinostat) Capsules

Date of Approval: February 23, 2015
Company: Secura Bio, Inc.
Treatment for: Multiple Myeloma

Farydak (panobinostat) is a histone deacetylase inhibitor for use in combination with bortezomib and dexamethasone to treat patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent. 

Avycaz (avibactam and ceftazidime) Injection

Date of Approval: February 25, 2015
Company: Actavis plc
Treatment for: Intraabdominal Infection, Urinary Tract Infection, Pneumonia

Avycaz (avibactam and ceftazidime) is a next generation, non-β lactam β-lactamase inhibitor and third-generation, antipseudomonal cephalosporin antibiotic combination for the treatment of complicated intra-abdominal infections, complicated urinary tract infections, hospital-acquired bacterial pneumonia, and ventilator-associated bacterial pneumonia.

Toujeo SoloStar (insulin glargine [rDNA origin]) Injection - formerly Toujeo

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

Toujeo SoloStar (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.

Liletta (levonorgestrel) Intrauterine Device

Date of Approval: February 26, 2015
Company: Medicines360 and Allergan plc
Treatment for: Birth Control

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

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: Emergent BioSolutions, Inc.
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.

Corlanor (ivabradine) Tablets and Oral Solution

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

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

Glatopa (glatiramer acetate) Injection

Date of Approval: April 16, 2015
Company: Sandoz Inc.
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.

Kybella (deoxycholic acid) Injection - formerly ATX-101

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

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

Ixinity (coagulation factor IX (recombinant))

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

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

Raplixa (fibrin sealant [human])

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

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

Tuzistra XR (chlorpheniramine polistirex and codeine polistirex) Extended Release Oral Suspension

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

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.

Invega Trinza (paliperidone palmitate) Extended-Release Injectable Suspension

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

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

Stiolto Respimat (olodaterol and tiotropium) Inhalation Spray

Date of Approval: May 21, 2015
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: COPD

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).

Viberzi (eluxadoline) Tablets

Date of Approval: May 27, 2015
Company: Allergan, Inc.
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.

Kengreal (cangrelor) for Injection

Date of Approval: June 22, 2015
Company: The Medicines Company
Treatment for: Percutaneous Coronary Intervention

Kengreal (cangrelor) is an intravenous P2Y12 platelet inhibitor indicated for use in patients undergoing Percutaneous Coronary Intervention (PCI) to reduce the risk of periprocedural thrombotic events.

Tuxarin ER (chlorpheniramine and codeine) Extended Release Tablets

Date of Approval: June 22, 2015
Company: Spriaso LLC
Treatment for: Cough, Cold Symptoms

Tuxarin ER (codeine and chlorpheniramine) is a long acting narcotic antitussive and antihistamine combination for the treatment of cough and cold symptoms.

Orkambi (ivacaftor and lumacaftor) Tablets and Oral Granules

Date of Approval: July 2, 2015
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis

Orkambi (ivacaftor and lumacaftor) is a CFTR potentiator and CFTR corrector combination for the treatment of the underlying cause of cystic fibrosis in patients 2 years and older with two copies of the F508del mutation in their CFTR gene.

Entresto (sacubitril and valsartan) Tablets - formerly LCZ696

Date of Approval: July 7, 2015
Company: Novartis Pharmaceuticals Corporation
Treatment for: Heart Failure

Entresto (sacubitril and valsartan) is a neprilysin inhibitor and angiotensin II receptor blocker combination indicated:

  • to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.
  • for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Entresto reduces NT-proBNP and is expected to improve cardiovascular outcomes.

Rexulti (brexpiprazole) Tablets

Date of Approval: July 10, 2015
Company: Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S
Treatment for: Schizophrenia; Major Depressive Disorder

Rexulti (brexpiprazole) is a serotonin-dopamine activity modulator (SDAM) for the treatment of schizophrenia and the adjunctive treatment of major depressive disorder.

Envarsus XR (tacrolimus) Extended-Release Tablets

Date of Approval: July 10, 2015
Company: Veloxis Pharmaceuticals A/S
Treatment for: Organ Transplant, Rejection Prophylaxis

Envarsus XR (tacrolimus) is a once-daily extended-release immunosuppressant for the prophylaxis of organ rejection in kidney transplant patients.

Epiduo Forte (adapalene and benzoyl peroxide) Topical Gel

Date of Approval: July 15, 2015
Company: Galderma Laboratories, L.P.
Treatment for: Acne

Epiduo Forte (adapalene and benzoyl peroxide) gel is a topical retinoid and benzoyl peroxide combination indicated for the topical treatment of acne vulgaris.

Technivie (ombitasvir, paritaprevir and ritonavir) Tablets

Date of Approval: July 24, 2015
Company: AbbVie Inc.
Treatment for: Hepatitis C

Marketing Status: Discontinued

Technivie (ombitasvir, paritaprevir and ritonavir) is an NS5A inhibitor, NS3/4A protease inhibitor, and CYP3A inhibitor fixed-dose combination indicated for use in combination with ribavirin for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection.

Odomzo (sonidegib) Capsules

Date of Approval: July 24, 2015
Company: Novartis Pharmaceuticals Corporation
Treatment for: Basal Cell Carcinoma

Odomzo (sonidegib) is a hedgehog pathway inhibitor indicated for the treatment of locally advanced basal cell carcinoma (BCC).

Praluent (alirocumab) Injection

Date of Approval: July 24, 2015
Company: Sanofi
Treatment for: High Cholesterol

Praluent (alirocumab) is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor monoclonal antibody indicated:

  • to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
  • as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol LDL-C.
  • as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

Daklinza (daclatasvir) Tablets

Date of Approval: July 24, 2015
Company: Bristol-Myers Squibb Company
Treatment for: Hepatitis C

Marketing Status: Discontinued

Daklinza (daclatasvir) is an NS5A inhibitor indicated for use in combination with sofosbuvir for the treatment of chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection.

Spritam (levetiracetam) Tablets for for Oral Suspension

Date of Approval: August 3, 2015
Company: Aprecia Pharmaceuticals Company
Treatment for: Seizures, Epilepsy

Spritam (levetiracetam) is an antiepileptic used in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures.

Keveyis (dichlorphenamide) Tablets

Date of Approval: August 7, 2015
Company: Taro Pharmaceutical Industries Ltd.
Treatment for: Primary Hyperkalemic and Hypokalemic Periodic Paralysis

Keveyis (dichlorphenamide) is an oral carbonic anhydrase inhibitor indicated for the treatment of primary hyperkalemic and hypokalemic periodic paralysis.

Addyi (flibanserin) Tablets

Date of Approval: August 18, 2015
Company: Sprout Pharmaceuticals, Inc.
Treatment for: Hypoactive Sexual Desire Disorder

Addyi (flibanserin) is a non-hormonal, multifunctional serotonin agonist antagonist (MSAA) for the treatment of hypoactive sexual desire disorder in premenopausal women.

Synjardy (empagliflozin and metformin) Tablets

Date of Approval: August 26, 2015
Company: Eli Lilly and Company and Boehringer Ingelheim
Treatment for: Diabetes, Type 2

Synjardy (empagliflozin and metformin hydrochloride) is a sodium glucose co-transporter-2 (SGLT2) inhibitor and biguanide combination for the treatment of adults with type 2 diabetes.

Repatha (evolocumab) Injection

Date of Approval: August 27, 2015
Company: Amgen Inc.
Treatment for: High Cholesterol; Prevention of Heart Attack and Stroke

Repatha (evolocumab) is a monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) used for the treatment of familial hypercholesterolemia (heterozygous and homozygous), and to reduce the risk of adverse cardiovascular events in adults with established cardiovascular disease (CVD).

Varubi (rolapitant) Tablets and Injection

Date of Approval: September 1, 2015
Company: Tesaro Inc.
Treatment for: Nausea/Vomiting, Chemotherapy Induced

Varubi (rolapitant) is a substance P/neurokinin 1 (NK1) receptor antagonist indicated for use in the prevention of delayed nausea and vomiting associated with emetogenic chemotherapy.

Xuriden (uridine triacetate) Oral Granules

Date of Approval: September 4, 2015
Company: Wellstat Therapeutics Corporation
Treatment for: Hereditary Orotic Aciduria

Xuriden (uridine triacetate) is an orally administered pyrimidine analog uridine replacement product for the treatment of patients with hereditary orotic aciduria.

Durlaza (aspirin) Extended Release Capsules

Date of Approval: September 4, 2015
Company: New Haven Pharmaceuticals, Inc.
Treatment for: Ischemic Stroke, Prophylaxis

Durlaza (aspirin) is a 24-hour, extended release aspirin formulation for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack).

Nuwiq (antihemophilic factor (recombinant)) for Injection

Date of Approval: September 4, 2015
Company: Octapharma USA, Inc.
Treatment for: Hemophilia A

Nuwiq (antihemophilic factor [recombinant]) is recombinant blood coagulation factor VIII indicated for the control and prevention of bleeding episodes in patients with hemophilia A.

Vraylar (cariprazine) Capsules

Date of Approval: September 17, 2015
Company: Allergan and Gedeon Richter plc
Treatment for: Schizophrenia, Bipolar Disorder

Vraylar (cariprazine) is a dopamine D3/D2 receptor partial agonist atypical antipsychotic for the:

  • treatment of schizophrenia in adults
  • acute treatment of manic or mixed episodes associated with bipolar I disorder in adults
  • treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults.

Lonsurf (tipiracil hydrochloride and trifluridine) Capsules

Date of Approval: September 22, 2015
Company: Taiho Oncology, Inc.
Treatment for: Colorectal Cancer, Gastric Cancer

Lonsurf (tipiracil and trifluridine) is a thymidine phosphorylase inhibitor and nucleoside metabolic inhibitor combination indicated for the treatment of patients with previously treated metastatic colorectal cancer, and previously treated metastatic gastric or gastroesophageal junction adenocarcinoma.

Ryzodeg 70/30 (insulin degludec and insulin aspart) Injection

Date of Approval: September 25, 2015
Company: Novo Nordisk
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Ryzodeg 70/30 (insulin degludec and insulin aspart) is a long-acting insulin analog and rapid-acting human insulin analog combination indicated to improve glycemic control in adults with diabetes mellitus.

Tresiba (insulin degludec) Injection

Date of Approval: September 25, 2015
Company: Novo Nordisk
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Tresiba (insulin degludec) is a long-acting basal insulin analogue indicated to improve glycemic control in patients one year of age and older with diabetes mellitus.

MorphaBond ER (morphine sulfate) Extended-Release Tablets

Date of Approval: October 2, 2015
Company: Inspirion Delivery Technologies, LLC
Treatment for: Pain

MorphaBond ER (morphine sulfate) is an extended-release, abuse-deterrent, opioid analgesic for the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

Aristada (aripiprazole lauroxil) Injection

Date of Approval: October 5, 2015
Company: Alkermes plc
Treatment for: Schizophrenia

Aristada (aripiprazole lauroxil) is an extended-release injectable atypical antipsychotic with one-month, six-week, and two-month dosing options for the treatment of schizophrenia.

Praxbind (idarucizumab) Injection

Date of Approval: October 16, 2015
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Reversal Agent for Pradaxa

Praxbind (idarucizumab) is a humanized monoclonal antibody fragment (Fab) indicated in patients treated with Pradaxa® (dabigatran) when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures; and in life-threatening or uncontrolled bleeding.

Enstilar (betamethasone dipropionate and calcipotriene) Foam

Date of Approval: October 16, 2015
Company: LEO Pharma
Treatment for: Plaque Psoriasis

Enstilar (betamethasone dipropionate and calcipotriene) is a topical corticosteroid and vitamin D analogue foam formulation for the treatment of psoriasis vulgaris.

Dyanavel XR (amphetamine) Extended-Release Oral Suspension and Extended-Release Tablets

Date of Approval: October 19, 2015
Company: Tris Pharma, Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Dyanavel XR (amphetamine) is an extended-release central nervous system (CNS) stimulant for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Coagadex (coagulation factor X (human)) Injection

Date of Approval: October 20, 2015
Company: Bio Products Laboratory Limited
Treatment for: Hereditary Factor X Deficiency

Coagadex (coagulation factor X (human)) is a human factor X concentrate for the treatment of hereditary factor X deficiency.

Veltassa (patiromer) for Oral Suspension

Date of Approval: October 21, 2015
Company: Relypsa, Inc.
Treatment for: Hyperkalemia

Veltassa (patiromer) is an oral potassium binder for the treatment of hyperkalemia.

Onivyde (irinotecan liposomal) Injection - formerly MM-398

Date of Approval: October 22, 2015
Company: Merrimack Pharmaceuticals, Inc.
Treatment for: Pancreatic Cancer

Onivyde (irinotecan liposome injection) is a liposomal formulation of the topoisomerase I inhibitor irinotecan indicated for the treatment of post-gemcitabine metastatic adenocarcinoma of the pancreas.

Yondelis (trabectedin) for Injection

Date of Approval: October 23, 2015
Company: Janssen Biotech, Inc.
Treatment for: Soft Tissue Sarcoma

Yondelis (trabectedin) is a cytotoxic antitumor agent for the treatment of unresectable or metastatic liposarcoma or leiomyosarcoma, two common subtypes of soft tissue sarcoma.

Strensiq (asfotase alfa) Injection

Date of Approval: October 23, 2015
Company: Alexion Pharmaceuticals, Inc.
Treatment for: Hypophosphatasia

Strensiq (asfotase alfa) is a tissue nonspecific alkaline phosphatase enzyme replacement therapy indicated for the treatment of patients with perinatal, infantile and juvenile-onset hypophosphatasia (HPP).

Vivlodex (meloxicam) Capsules

Date of Approval: October 22, 2015
Company: Iroko Pharmaceuticals, LLC
Treatment for: Osteoarthritis

Vivlodex (meloxicam) is a low dose nonsteroidal anti-inflammatory drug (NSAID) indicated for the management of osteoarthritis pain.

Belbuca (buprenorphine hydrochloride) Buccal Film

Date of Approval: October 23, 2015
Company: Endo Pharmaceuticals Inc.
Treatment for: Chronic Pain

Belbuca (buprenorphine) is a partial opioid agonist analgesic in a buccal film formulation for the management of chronic pain.

Imlygic (talimogene laherparepvec) Injection

Date of Approval: October 27, 2015
Company: Amgen Inc.
Treatment for: Melanoma

Imlygic (talimogene laherparepvec) is a genetically modified oncolytic viral therapy indicated for the local treatment of melanoma lesions in the skin and lymph nodes.

Utibron Neohaler (glycopyrrolate and indacaterol) Inhalation Powder

Date of Approval: October 29, 2015
Company: Novartis Pharmaceuticals Corporation
Treatment for: COPD

Utibron Neohaler (glycopyrrolate and indacaterol) is a long-acting muscarinic antagonist (LAMA) and long-acting beta2-adrenergic agonist (LABA) fixed-dose combination for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

Seebri Neohaler (glycopyrrolate) Inhalation Powder

Date of Approval: October 29, 2015
Company: Novartis Pharmaceuticals Corporation
Treatment for: COPD

Seebri Neohaler (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

Nucala (mepolizumab) Injection

Date of Approval: November 4, 2015
Company: GlaxoSmithKline plc
Treatment for: Eosinophilic Asthma; Chronic Rhinosinusitis with Nasal Polyps; Eosinophilic Granulomatosis with Polyangiitis; Hypereosinophilic Syndrome

Nucala (mepolizumab) is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) used for the treatment of with severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), and hypereosinophilic syndrome (HES).

Genvoya (cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide) Tablets

Date of Approval: November 5, 2015
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide or E/C/F/TAF) is an antiretroviral combination for the treatment of HIV infection.

Cotellic (cobimetinib) Tablets

Date of Approval: November 10, 2015
Company: Genentech, Inc.
Treatment for: Melanoma, Metastatic

Cotellic (cobimetinib) is a kinase inhibitor indicated for use in combination with vemurafenib for the treatment of advanced melanoma with a BRAF V600E or V600K mutation.

Tagrisso (osimertinib) Tablets

Date of Approval: November 13, 2015
Company: AstraZeneca Pharmaceuticals
Treatment for: Non-Small Cell Lung Cancer

Tagrisso (osimertinib) is a tyrosine kinase inhibitor (TKI) of epidermal growth factor receptor (EGFR) indicated:
    • as adjuvant therapy after tumor resection in adult patients with non small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
    • for the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
    • for the treatment of adult patients with metastatic EGFR T790M mutationpositive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.

Adynovate (antihemophilic factor (recombinant) pegylated)

Date of Approval: November 13, 2015
Company: Baxalta Incorporated
Treatment for: Hemophilia A

Adynovate (antihemophilic factor (recombinant) pegylated) is a human antihemophilic factor indicated for the control and prevention of bleeding episodes in patients with hemophilia A.

Darzalex (daratumumab) Injection

Date of Approval: November 16, 2015
Company: Janssen Biotech, Inc.
Treatment for: Multiple Myeloma

Darzalex (daratumumab) is a human anti-CD38 monoclonal antibody indicated for the treatment of patients with multiple myeloma.

Narcan (naloxone) Nasal Spray

Date of Approval: November 18, 2015
Company: Emergent BioSolutions, Inc.
Treatment for: Opioid Overdose

Narcan Nasal Spray (naloxone) is an intranasal opioid antagonist formulation indicated for the emergency treatment of known or suspected opioid overdose.

Ninlaro (ixazomib) Capsules

Date of Approval: November 20, 2015
Company: Takeda Pharmaceutical Company Limited
Treatment for: Multiple Myeloma

Ninlaro (ixazomib) is an oral proteasome inhibitor indicated for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Portrazza (necitumumab) Injection

Date of Approval: November 24, 2015
Company: Eli Lilly and Company
Treatment for: Non-Small Cell Lung Cancer

Portrazza (necitumumab) is an epidermal growth factor receptor (EGFR) antagonist indicated in combination with gemcitabine and cisplatin for the treatment of patients with metastatic squamous non-small cell lung cancer.

Fluad (influenza vaccine, adjuvanted) Injection

Date of Approval: November 24, 2015
Company: Seqirus
Treatment for: Influenza Prophylaxis

Fluad (influenza vaccine, adjuvanted) is an inactivated influenza virus vaccine indicated for the prevention of seasonal influenza in people 65 years of age and older.

Empliciti (elotuzumab) Injection

Date of Approval: November 30, 2015
Company: Bristol-Myers Squibb Company and AbbVie
Treatment for: Multiple Myeloma

Empliciti (elotuzumab) is a Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody indicated for the combination treatment of patients with multiple myeloma.

QuilliChew ER (methylphenidate hydrochloride) Extended Release Chewable Tablets

Date of Approval: December 7, 2015
Company: Pfizer Inc.
Treatment for: Attention Deficit Hyperactivity Disorder

QuilliChew ER (methylphenidate hydrochloride) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Vonvendi (von willebrand factor (recombinant)) for Injection

Date of Approval: December 8, 2015
Company: Baxalta Incorporated
Treatment for: von Willebrand Disease

Vonvendi (von Willebrand factor (recombinant)) is a recombinant von Willebrand factor for the treatment of von Willebrand disease(VWD).

Kanuma (sebelipase alfa) Injection

Date of Approval: December 8, 2015
Company: Alexion Pharmaceuticals, Inc.
Treatment for: Lysosomal Acid Lipase Deficiency

Kanuma (sebelipase alfa) is an enzyme replacement therapy for the treatment of lysosomal acid lipase deficiency (LAL-D).

Bendeka (bendamustine hydrochloride) Injection

Date of Approval: December 7, 2015
Company: Eagle Pharmaceuticals, Inc.
Treatment for: Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma

Bendeka (bendamustine hydrochloride) is an alkylating drug indicated for treatment of patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Otiprio (ciprofloxacin) Otic Suspension - formerly AuriPro

Date of Approval: December 10, 2015
Company: Otonomy, Inc.
Treatment for: Tympanostomy Tube Placement Surgery; Acute Otitis Externa

Otiprio (ciprofloxacin otic suspension) is a single-dose, physician-administered, sustained-exposure otic fluoroquinolone antibacterial for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement surgery, and for the treatment of acute otitis externa due to Pseudomonas aeruginosa and Staphylococcus aureus.

Vistogard (uridine triacetate) Oral Granules

Date of Approval: December 11, 2015
Company: Wellstat Therapeutics Corporation
Treatment for: Fluorouracil Overdose and Capecitabine Overdose

Vistogard (uridine triacetate) is a pyrimidine analog indicated for the emergency treatment of adults and children who receive an overdose of the cancer treatments fluorouracil or capecitabine.

Alecensa (alectinib) Capsules

Date of Approval: December 11, 2015
Company: Genentech, Inc.
Treatment for: Non-Small Cell Lung Cancer

Alecensa (alectinib) is an oral, anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK-positive non-small cell lung cancer (NSCLC).

Bridion (sugammadex) Injection

Date of Approval: December 15, 2015
Company: Merck & Co., Inc.
Treatment for: Reversal of Nondepolarizing Muscle Relaxants

Bridion (sugammadex) is a novel selective relaxant binding agent (SRBA) for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.

Basaglar (insulin glargine) Injection

Date of Approval: December 16, 2015
Company: Eli Lilly and Company and Boehringer Ingelheim
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Basaglar (insulin glargine injection) is a long-acting human insulin analog indicated to improve glycemic control in patients with type 1 and type 2 diabetes mellitus.

Zurampic (lesinurad) Tablets

Date of Approval: December 22, 2015
Company: Ironwood Pharmaceuticals, Inc.
Treatment for: Hyperuricemia Associated with Gout

Marketing Status: Discontinued

Zurampic (lesinurad) is a URAT1 inhibitor indicated for the combination treatment of hyperuricemia associated with gout.

Uptravi (selexipag) Tablets and Lyophilized Powder for Injection

Date of Approval: December 21, 2015
Company: Actelion Pharmaceuticals US, Inc.
Treatment for: Pulmonary Arterial Hypertension

Uptravi (selexipag) is a prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension (PAH).

Docetaxel Non-Alcohol Formula () Injection

Date of Approval: December 22, 2015
Company: Eagle Pharmaceuticals, Inc.
Treatment for: Cancer

Docetaxel Injection, Non-Alcohol Formula is an alcohol-free formulation of docetaxel for use in the treatment of patients with breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

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