New Drug Approvals Archive 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.

• Impax Pharmaceuticals Announce FDA Approval of Rytary (carbidopa and levodopa) for Parkinson's Disease
• Rytary (carbidopa and levodopa) FDA Approval History

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.

• FDA Approves Savaysa (edoxaban) to Prevent Embolic Events in Non-Valvular Atrial Fibrillation
• Savaysa (edoxaban) FDA Approval History

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.

• FDA Approves Duopa (carbidopa and levodopa) Enteral Suspension for Parkinson's Disease
• Duopa (carbidopa and levodopa) FDA Approval History

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).

• Baxter Receives FDA Approval for Phoxillum Solution for Electrolyte Management During Continuous Renal Replacement Therapy
• Phoxillum (renal replacement solution) FDA Approval History

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, Enthesitis-Related Arthritis, Hidradenitis Suppurativa

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

• FDA Approves Cosentyx (secukinumab) for Plaque Psoriasis
• Cosentyx (secukinumab) FDA Approval History

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.

• FDA Approves Prestalia (amlodipine and perindopril) for Hypertension
• Prestalia (amlodipine besylate and perindopril arginine) FDA Approval History

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.

• FDA Approves Natpara (parathyroid hormone) for Hypocalcemia in Patients with Hypoparathyroidism
• Natpara (parathyroid hormone) FDA Approval History

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.

• FDA Approves Bexsero Vaccine to Prevent Serogroup B Meningococcal Disease
• Bexsero (meningococcal group B vaccine) FDA Approval History

Triferic (ferric pyrophosphate citrate)

Date of Approval: January 23, 2015
Company: Rockwell Medical, Inc.
Treatment for: Anemia Due to Chronic Kidney Disease

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

• FDA Approves Triferic for Iron Replacement and Maintenance of Hemoglobin in Hemodialysis Patients
• Triferic (ferric pyrophosphate citrate) FDA Approval History

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.

• FDA Approves Evotaz (atazanavir and cobicistat) for HIV-1 Infection in Adults
• Evotaz (atazanavir and cobicistat) FDA Approval History

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 protease inhibitor and pharmacokinetic enhancer combination for the treatment of HIV-1 infection.

• FDA Approves Prezcobix (darunavir and cobicistat) for HIV-1 Infection in Adults
• Prezcobix (cobicistat and darunavir) FDA Approval History

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.

• Alcon Receives FDA Approval of Pazeo (olopatadine HCl) Ophthalmic Solution for Allergic Conjunctivitis
• Pazeo (olopatadine hydrochloride) FDA Approval History

Glyxambi (empagliflozin and linagliptin) Tablets

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

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.

• FDA Approves Glyxambi (empagliflozin and linagliptin) for Type 2 Diabetes
• Glyxambi (empagliflozin and linagliptin) FDA Approval History

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 used for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

• FDA Approves Ibrance (palbociclib) for Postmenopausal Women with Advanced Breast Cancer
• Ibrance (palbociclib) FDA Approval History

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.

• FDA Approves Dutrebis (lamivudine and raltegravir) for HIV-1 Infection
• Dutrebis (lamivudine and raltegravir) FDA Approval History

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.

• FDA Approves Lenvima (lenvatinib) for Differentiated Thyroid Cancer
• Lenvima (lenvatinib) FDA Approval History

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. 

• FDA Approves Farydak (panobinostat) for Multiple Myeloma
• Farydak (panobinostat) FDA Approval History

Avycaz (avibactam and ceftazidime) Injection

Date of Approval: February 25, 2015
Company: AbbVie Inc.
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.

• FDA Approves Avycaz (ceftazidime and avibactam) for Complicated Abdominal and Urinary Tract Infections
• Avycaz (avibactam and ceftazidime) FDA Approval History

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

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

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.

• Sanofi Receives FDA Approval of Once-Daily Basal Insulin Toujeo
• Toujeo SoloStar (insulin glargine [rDNA origin]) FDA Approval History

Liletta (levonorgestrel) Intrauterine Device

Date of Approval: February 26, 2015
Company: AbbVie Inc.
Treatment for: Birth Control, Heavy Menstrual Bleeding

Liletta (levonorgestrel) is a progestin-containing intrauterine system indicated for the prevention of pregnancy for up to 8 years, and the treatment of heavy menstrual bleeding for up to 5 years in patients who choose intrauterine contraception as their method of contraception.

• FDA Approves Liletta (levonorgestrel-releasing intrauterine system) to Prevent Pregnancy for up to Three Years
• Liletta (levonorgestrel) FDA Approval History

Zarxio (filgrastim-sndz) Injection

Date of Approval: March 6, 2015
Company: Sandoz
Treatment for: Neutropenia Associated with Chemotherapy, Neutropenia, Neutropenia Associated with Radiation, Bone Marrow Transplantation, Peripheral Progenitor Cell Transplantation, Hematopoietic Syndrome of Acute Radiation Syndrome

Zarxio (filgrastim-sndz) is a leukocyte growth factor biosimilar to Neupogen (filgrastim).

• 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

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

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.

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

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

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.

• FDA Approves Corlanor (ivabradine) to Treat Heart Failure
• Corlanor (ivabradine) FDA Approval History

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.

• FDA Approves Glatopa (glatiramer acetate) as the First Generic Competitor to Copaxone
• Glatopa (glatiramer acetate) FDA Approval History

Kybella (deoxycholic acid) Injection - formerly ATX-101

Date of Approval: April 29, 2015
Company: AbbVie 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).

• FDA Approves Kybella (deoxycholic acid) to Treat Submental Fullness, or 'Double Chin'
• Kybella (deoxycholic acid) FDA Approval History

Ixinity (coagulation factor IX (recombinant)) for Injection

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 used to prevent bleeding in patients with hemophilia B.

• Emergent BioSolutions Announces FDA Approval of Ixinity [coagulation factor IX (recombinant)] for Hemophilia B
• Ixinity (coagulation factor IX (recombinant)) FDA Approval History

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.

• FDA Approves Raplixa (fibrin sealant [human]) to Control Bleeding During Surgery
• Raplixa (fibrin sealant [human]) FDA Approval History

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

Date of Approval: April 30, 2015
Company: 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.

• Vernalis and Tris Pharma Receive FDA Approval for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex)
• Tuzistra XR (chlorpheniramine polistirex and codeine polistirex) FDA Approval History

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.

• FDA Approves Invega Trinza (paliperidone palmitate) Four-Times-A-Year Treatment for Schizophrenia
• Invega Trinza (paliperidone palmitate) FDA Approval History

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).

• FDA Approves Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray for COPD
• Stiolto Respimat (olodaterol and tiotropium) FDA Approval History

Viberzi (eluxadoline) Tablets

Date of Approval: May 27, 2015
Company: AbbVie 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.

• FDA Approves Viberzi (eluxadoline) for Irritable Bowel Syndrome with Diarrhea (IBS-D) in Adults
• Viberzi (eluxadoline) FDA Approval History

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.

• FDA Approves Antiplatelet Agent Kengreal (cangrelor) as Adjunct to Percutaneous Coronary Intervention
• Kengreal (cangrelor) FDA Approval History

Tuxarin ER (chlorpheniramine and codeine) Extended Release Tablets

Date of Approval: June 22, 2015
Company: Mainpointe Pharmaceuticals
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.

• Spriaso Announces FDA Approval of Long Acting Tuxarin ER (codeine and chlorpheniramine)
• Tuxarin ER (chlorpheniramine and codeine) FDA Approval History

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 cystic fibrosis transmembrane conductance regulator (CFTR) potentiator and CFTR corrector combination for the treatment of cystic fibrosis in patients 1 year of age and older who have two copies of the F508del mutation (F508del/F508del) in their CFTR gene.

• FDA Approves Orkambi (lumacaftor/ivacaftor) for Cystic Fibrosis
• Orkambi (ivacaftor and lumacaftor) FDA Approval History

Entresto (sacubitril and valsartan) Tablets and Sprinkle Capsules

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 used in the treatment of heart failure.

• FDA Approves Entresto (sacubitril/valsartan) for Heart Failure
• Entresto (sacubitril and valsartan) FDA Approval History

Rexulti (brexpiprazole) Tablets

Date of Approval: July 10, 2015
Company: Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S
Treatment for: Major Depressive Disorder, Schizophrenia, Agitation Associated with Dementia Due to Alzheimer’s Disease

Rexulti (brexpiprazole) is an atypical antipsychotic for use in the treatment of major depressive disorder (MDD), schizophrenia, and agitation associated with dementia due to Alzheimer’s disease.

• FDA Approves Rexulti (brexpiprazole) for Schizophrenia and Adjunctive Treatment for Major Depressive Disorder
• Rexulti (brexpiprazole) FDA Approval History

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.

• FDA Approves Envarsus XR (tacrolimus) for Prevention of Organ Rejection in Kidney Transplant Patients
• Envarsus XR (tacrolimus) FDA Approval History

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.

• Galderma Receives FDA Approval for Epiduo Forte (adapalene and benzoyl peroxide) for Acne
• Epiduo Forte (adapalene and benzoyl peroxide) FDA Approval History

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.

• FDA Approves Technivie (ombitasvir, paritaprevir and ritonavir) for Chronic Hepatitis C Genotype 4 Infections
• Technivie (ombitasvir, paritaprevir and ritonavir) FDA Approval History

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).

• FDA Approves Odomzo (sonidegib) for Locally Advanced Basal Cell Carcinoma
• Odomzo (sonidegib) FDA Approval History

Praluent (alirocumab) Injection

Date of Approval: July 24, 2015
Company: Sanofi
Treatment for: High Cholesterol, High Cholesterol, Familial Heterozygous, High Cholesterol, Familial Homozygous, Cardiovascular Risk Reduction

Praluent (alirocumab) is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor monoclonal antibody used for the treatment of familial hypercholesterolemia and to reduce the risk of cardiovascular events in people with cardiovascular disease.

• FDA Approves Praluent (alirocumab) to Treat Certain Patients with High Cholesterol
• Praluent (alirocumab) FDA Approval History

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.

• FDA Approves Daklinza (daclatasvir) for Chronic Hepatitis C Genotype 3 Infections
• Daklinza (daclatasvir) FDA Approval History

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.

• FDA Approves Spritam (levetiracetam) as the First 3D Printed Drug Product
• Spritam (levetiracetam) FDA Approval History

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.

• FDA Approves Keveyis (dichlorphenamide) for Primary Hyperkalemic and Hypokalemic Periodic Paralysis
• Keveyis (dichlorphenamide) FDA Approval History

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.

• FDA Approves Addyi (flibanserin) for Hypoactive Sexual Desire Disorder in Premenopausal Women
• Addyi (flibanserin) FDA Approval History

Synjardy (empagliflozin and metformin) Tablets

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

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

• FDA Approves Synjardy (empagliflozin/metformin hydrochloride) for Type 2 Diabetes
• Synjardy (empagliflozin and metformin) FDA Approval History

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).

• FDA Approves Repatha (evolocumab) to Treat Certain Patients with High Cholesterol
• Repatha (evolocumab) FDA Approval History

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.

• FDA Approves Varubi (rolapitant) for Chemotherapy-Induced Nausea and Vomiting
• Varubi (rolapitant) FDA Approval History

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.

• FDA Approves Xuriden (uridine triacetate) to Treat Hereditary Orotic Aciduria
• Xuriden (uridine triacetate) FDA Approval History

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).

• FDA Approves Durlaza (aspirin) ER Capsules for Secondary Prevention of Stroke and Acute Cardiac Events
• Durlaza (aspirin) FDA Approval History

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.

• FDA Approves Nuwiq (Antihemophilic Factor [Recombinant]) for Hemophilia A
• Nuwiq (antihemophilic factor (recombinant)) FDA Approval History

Vraylar (cariprazine) Capsules

Date of Approval: September 17, 2015
Company: AbbVie Inc.
Treatment for: Schizophrenia, Bipolar Disorder, Major Depressive Disorder

Vraylar (cariprazine) is an atypical antipsychotic for the treatment of schizophrenia, bipolar I disorder, and major depressive disorder.

• FDA Approves Vraylar (cariprazine) for Schizophrenia and Bipolar Disorder
• Vraylar (cariprazine) FDA Approval History

Lonsurf (tipiracil hydrochloride and trifluridine) Tablets

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

Lonsurf (tipiracil hydrochloride and trifluridine) is a thymidine phosphorylase inhibitor and nucleoside metabolic inhibitor combination used for the treatment of colorectal cancer and gastric or gastroesophageal junction adenocarcinoma.

• FDA Approves Lonsurf (tipiracil and trifluridine) for Advanced Colorectal Cancer
• Lonsurf (tipiracil hydrochloride and trifluridine) FDA Approval History

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

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

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.

• FDA Approves Ryzodeg 70/30 (insulin degludec/insulin aspart) for Diabetes Mellitus
• Ryzodeg 70/30 (insulin degludec and insulin aspart) FDA Approval History

Tresiba (insulin degludec) Injection

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

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.

• FDA Approves Tresiba (insulin degludec) for Diabetes Mellitus
• Tresiba (insulin degludec) FDA Approval History

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.

• FDA Approves MorphaBond (morphine sulfate) Extended-Release Tablets with Abuse-Deterrent Properties
• MorphaBond ER (morphine sulfate) FDA Approval History

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.

• FDA Approves Aristada (aripiprazole lauroxil) for Schizophrenia
• Aristada (aripiprazole lauroxil) FDA Approval History

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.

• FDA Approves Praxbind (idarucizumab) as a Reversal Agent for the Anticoagulant Pradaxa
• Praxbind (idarucizumab) FDA Approval History

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.

• LEO Pharma Announces U.S. Approval of Enstilar Foam (calcipotriene/betamethasone dipropionate) for Plaque Psoriasis
• Enstilar (betamethasone dipropionate and calcipotriene) FDA Approval History

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).

• Tris Pharma Receives FDA Approval of Dyanavel XR (amphetamine) Once-Daily Liquid for ADHD in Children
• Dyanavel XR (amphetamine) FDA Approval History

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.

• FDA Approves Coagadex (coagulation factor X (human)) for Hereditary Factor X Deficiency
• Coagadex (coagulation factor X (human)) FDA Approval History

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.

• FDA Approves Veltassa (patiromer) for Hyperkalemia
• Veltassa (patiromer) FDA Approval History

Onivyde (irinotecan liposomal) Injection

Date of Approval: October 22, 2015
Company: Ipsen Biopharmaceuticals, Inc.
Treatment for: Pancreatic Cancer

Onivyde (irinotecan liposome injection) is a liposomal formulation of the topoisomerase I inhibitor irinotecan used in the treatment of pancreatic adenocarcinoma.

• FDA Approves Onivyde (irinotecan liposome injection) for Advanced Pancreatic Cancer
• Onivyde (irinotecan liposomal) FDA Approval History

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.

• FDA Approves Yondelis (trabectedin) for the Treatment of Specific Soft Tissue Sarcomas
• Yondelis (trabectedin) FDA Approval History

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).

• FDA Approves Strensiq (asfotase alfa) for Perinatal, Infantile and Juvenile-Onset Hypophosphatasia
• Strensiq (asfotase alfa) FDA Approval History

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.

• FDA Approves Vivlodex (meloxicam) for Osteoarthritis Pain
• Vivlodex (meloxicam) FDA Approval History

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.

• FDA Approves Belbuca (buprenorphine) Buccal Film for Chronic Pain Management
• Belbuca (buprenorphine hydrochloride) FDA Approval History

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.

• FDA Approves Imlygic (talimogene laherparepvec) for the Treatment of Melanoma
• Imlygic (talimogene laherparepvec) FDA Approval History

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).

• FDA Approves Utibron Neohaler (indacaterol/glycopyrrolate) for COPD
• Utibron Neohaler (glycopyrrolate and indacaterol) FDA Approval History

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).

• FDA Approves Seebri Neohaler (glycopyrrolate) for COPD
• Seebri Neohaler (glycopyrrolate) FDA Approval History

Nucala (mepolizumab) Injection

Date of Approval: November 4, 2015
Company: GlaxoSmithKline plc
Treatment for: Asthma, Chronic Rhinosinusitis With Nasal Polyps, COPD, 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, chronic obstructive pulmonary disease, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome.

• FDA Approves Nucala (mepolizumab) to Treat Severe Asthma
• Nucala (mepolizumab) FDA Approval History

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.

• FDA Approves Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) for HIV
• Genvoya (cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide) FDA Approval History

Cotellic (cobimetinib) Tablets

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

Cotellic (cobimetinib) is an MEK inhibitor for the treatment of melanoma and histiocytic neoplasms.

• FDA Approves Cotellic (cobimetinib) for the Combination Treatment of Advanced Melanoma
• Cotellic (cobimetinib) FDA Approval History

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 used for the treatment of epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

• FDA Approves Tagrisso (osimertinib) for EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer
• Tagrisso (osimertinib) FDA Approval History

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.

• FDA Approves Adynovate Modified Antihemophilic Factor for Hemophilia A
• Adynovate (antihemophilic factor (recombinant) pegylated) FDA Approval History

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.

• FDA Approves Darzalex (daratumumab) for Patients with Previously Treated Multiple Myeloma
• Darzalex (daratumumab) FDA Approval History

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.

• FDA Approves Narcan (naloxone) Nasal Spray to Treat Opioid Overdose
• Narcan (naloxone) FDA Approval History

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.

• FDA Approves Ninlaro (ixazomib) for Multiple Myeloma
• Ninlaro (ixazomib) FDA Approval History

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.

• FDA Approves Portrazza (necitumumab) for Advanced Squamous Non-Small Cell Lung Cancer
• Portrazza (necitumumab) FDA Approval History

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.

• FDA Approves Fluad (influenza vaccine, adjuvanted) for Prevention of Seasonal Influenza
• Fluad (influenza vaccine, adjuvanted) FDA Approval History

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.

• FDA Approves Empliciti (elotuzumab) for Multiple Myeloma
• Empliciti (elotuzumab) FDA Approval History

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).

• Pfizer Receives FDA Approval for QuilliChew ER (methylphenidate hydrochloride) Extended-Release Chewable Tablets
• QuilliChew ER (methylphenidate hydrochloride) FDA Approval History

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).

• FDA Approves Vonvendi (Von Willebrand Factor (Recombinant)) to Treat Bleeding Episodes in Patients with VWD
• Vonvendi (von willebrand factor (recombinant)) FDA Approval History

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).

• FDA Approves Kanuma (sebelipase alfa) for Lysosomal Acid Lipase Deficiency
• Kanuma (sebelipase alfa) FDA Approval History

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.

• Teva Pharmaceuticals and Eagle Pharmaceuticals Announce FDA Approval of Bendeka (bendamustine hydrochloride) Injection
• Bendeka (bendamustine hydrochloride) FDA Approval History

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.

• FDA Approves Otiprio (ciprofloxacin otic suspension) for the Treatment of Pediatric Patients Undergoing Tympanostomy Tube Placement Surgery
• Otiprio (ciprofloxacin) FDA Approval History

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.

• FDA Approves Vistogard (uridine triacetate) for Emergency Treatment for Overdose of Certain Types of Chemotherapy
• Vistogard (uridine triacetate) FDA Approval History

Alecensa (alectinib) Capsules

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

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

• FDA Approves Alecensa (alectinib) for ALK-Positive Non-Small Cell Lung Cancer
• Alecensa (alectinib) FDA Approval History

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.

• FDA Approves Bridion (sugammadex) to Reverse Effects of Neuromuscular Blocking Drugs
• Bridion (sugammadex) FDA Approval History

Basaglar (insulin glargine) Injection

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

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.

• FDA Approves Basaglar (insulin glargine) for Type 1 and Type 2 Diabetes
• Basaglar (insulin glargine) FDA Approval History

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.

• FDA Approves Zurampic (lesinurad) to Treat High Blood Uric Acid Levels Associated with Gout
• Zurampic (lesinurad) FDA Approval History

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).

• FDA Approves Uptravi (selexipag) for Pulmonary Arterial Hypertension
• Uptravi (selexipag) FDA Approval History

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.

• Teikoku Pharma USA, Inc. Announces FDA Approval of Docetaxel Injection, Non-Alcohol Formula
• Docetaxel Non-Alcohol Formula FDA Approval History