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New Drug Approvals Archive for 2014

See also: New Indications and Dosage Forms for 2014

Farxiga (dapagliflozin) Tablets

Date of Approval: January 8, 2014
Company: AstraZeneca
Treatment for: Diabetes, Type 2, Renal Failure, Heart Failure

Farxiga (dapagliflozin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated for the treatment of type 2 diabetes mellitus, heart failure, and chronic kidney disease.

Aleve PM (diphenhydramine hydrochloride and naproxen sodium) Caplets

Date of Approval: January 16, 2014
Company: Bayer HealthCare LLC, Consumer Care
Treatment for: Pain, Insomnia

Aleve PM (diphenhydramine hydrochloride and naproxen sodium) is an over-the-counter antihistamine and nonsteroidal anti-inflammatory drug (NSAID) combination for the relief of occasional sleeplessness associated with minor aches and pains.

Hetlioz (tasimelteon) Capsules

Date of Approval: January 31, 2014
Company: Vanda Pharmaceuticals Inc.
Treatment for: Non-24-Hour Disorder; Smith-Magenis Syndrome Sleep Disturbance

Hetlioz (tasimelteon) is a melatonin receptor agonist for the treatment of Non-24-Hour Disorder in adults, and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older.

Vimizim (elosufase alfa) Injection

Date of Approval: February 14, 2014
Company: BioMarin Pharmaceutical Inc.
Treatment for: Mucopolysaccharidosis Type IVA

Vimizim (elosufase alfa) is an enzyme replacement therapy for patients with Mucopolysaccharidosis Type IVA (Morquio A syndrome).

Northera (droxidopa) Capsules

Date of Approval: February 18, 2014
Company: Chelsea Therapeutics International, Ltd.
Treatment for: Neurogenic Orthostatic Hypotension

Northera (droxidopa) is an orally active synthetic precursor of norepinephrine indicated for the treatment of neurogenic orthostatic hypotension.

Myalept (metreleptin) Injection

Date of Approval: February 24, 2014
Company: Amylin Pharmaceuticals, Inc.
Treatment for: Lipodystrophy

Myalept (metreleptin) is a leptin analog indicated to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.

Tivorbex (indomethacin) Capsules

Date of Approval: February 24, 2014
Company: Iroko Pharmaceuticals, LLC
Treatment for: Pain

Tivorbex (indomethacin) is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of mild to moderate acute pain.

Monovisc (sodium hyaluronate) Injection

Date of Approval: February 24, 2014
Company: Anika Therapeutics, Inc.
Treatment for: Osteoarthritis

Monovisc (sodium hyaluronate) is a viscoelastic supplement indicated for the treatment of pain associated with osteoarthritis of the knee.

Aveed (testosterone undecanoate) Intramuscular Injection - formerly Nebido

Date of Approval: March 5, 2014
Company: Endo Pharmaceuticals
Treatment for: Hypogonadism, Male

Aveed (testosterone undecanoate) is a long-acting androgen depot injection for the treatment of male hypogonadism.

Xartemis XR (acetaminophen and oxycodone hydrochloride) Extended-Release Tablets

Date of Approval: March 11, 2014
Company: Mallinckrodt
Treatment for: Pain

Marketing Status: Discontinued

Xartemis XR (acetaminophen and oxycodone hydrochloride) is an extended-release analgesic and opioid agonist formulation for the management of moderate to severe acute pain.

Qudexy XR (topiramate) Extended-Release Capsules

Date of Approval: March 11, 2014
Company: Upsher-Smith Laboratories, Inc.
Treatment for: Seizures, Lennox-Gastaut Syndrome, Migraine Prevention

Qudexy XR (topiramate) is an antiepileptic drug indicated for the treatment of partial onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut Syndrome in adults and children; and for the prophylaxis of migraine headache in adults and adolescents.

Hemangeol (propranolol hydrochloride) Oral Solution

Date of Approval: March 14, 2014
Company: Pierre Fabre Dermatologie
Treatment for: Infantile Hemangioma

Hemangeol (propranolol hydrochloride) is a pediatric beta-blocker formulation indicated for the treatment of proliferating infantile hemangioma.

Impavido (miltefosine) Capsules

Date of Approval: March 19, 2014
Company: Paladin Labs Inc.
Treatment for: Leishmaniasis

Impavido (miltefosine) is an oral alkylphosphocholine antiparasitic for the treatment of leishmaniasis.

Neuraceq (florbetaben F18) Injection

Date of Approval: March 19, 2014
Company: Piramal Imaging
Treatment for: Positron Emission Tomography Imaging

Neuraceq (florbetaben F18) is a radioactive diagnostic agent indicated for PET imaging of the brain to estimate β-amyloid neuritic plaquedensity in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline.

Otezla (apremilast) Tablets

Date of Approval: March 21, 2014
Company: Celgene Corporation
Treatment for: Psoriatic Arthritis, Plaque Psoriasis, Behcet's Disease

Otezla (apremilast) is a phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of psoriatic arthritis, plaque psoriasis, and oral ulcers associated with Behçet’s Disease.

Alprolix (coagulation factor IX (recombinant))

Date of Approval: March 28, 2014
Company: Biogen Idec, Inc.
Treatment for: Hemophilia B

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

Evzio (naloxone hydrochloride)

Date of Approval: April 3, 2014
Company: Kaleo Inc.
Treatment for: Opioid Overdose

Evzio (naloxone hydrochloride) is an opioid antagonist hand-held auto-injector indicated for the emergency treatment of known or suspected opioid overdose.

Tanzeum (albiglutide) Injection

Date of Approval: April 15, 2014
Company: GlaxoSmithKline (GSK) plc
Treatment for: Diabetes, Type 2

Tanzeum (albiglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of type 2 diabetes.

Ragwitek (ragweed pollen allergen extract)

Date of Approval: April 17, 2014
Company: Merck & Co., Inc.
Treatment for: Ragweed Allergies

Ragwitek (short ragweed pollen allergen extract) is a sublingual immunotherapy for the treatment of ragweed allergies.

Xulane (ethinyl estradiol and norelgestromin) Transdermal System

Date of Approval: April 16, 2014
Company: Mylan Inc.
Treatment for: Birth Control

Xulane (ethinyl estradiol and norelgestromin transermal system) is a generic version of Ortho Evra, a birth control patch used to prevent pregnancy.

Cyramza (ramucirumab) Injection

Date of Approval: April 21, 2014
Company: Eli Lilly and Company
Treatment for: Gastric Cancer, Non-Small Cell Lung Cancer, Colorectal Cancer, Hepatocellular Carcinoma

Cyramza (ramucirumab) is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated:

  • as a single agent or in combination with paclitaxel, for treatment of advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
  • in combination with erlotinib, for first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
  • in combination with docetaxel, for treatment of metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy.
  • in combination with FOLFIRI, for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
  • as a single agent, for the treatment of hepatocellular carcinoma in patients who have an alpha fetoprotein of ≥400 ng/mL and have been treated with sorafenib.

Sylvant (siltuximab) for Injection

Date of Approval: April 22, 2014
Company: Janssen Research & Development, LLC
Treatment for: Multicentric Castleman's Disease

Sylvant (siltuximab) is an interleukin-6 (IL-6) antagonist indicated for the treatment of patients with multicentric Castleman’s disease.

Zykadia (ceritinib) Capsules

Date of Approval: April 29, 2014
Company: Novartis Pharmaceuticals Corporation
Treatment for: Non-Small Cell Lung Cancer

Zykadia (ceritinib) is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer.

Purixan (mercaptopurine) Oral Suspension

Date of Approval: April 28, 2014
Company: Nova Laboratories, Ltd.
Treatment for: Acute Lymphoblastic Leukemia

Purixan (mercaptopurine) is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia.

Incruse Ellipta (umeclidinium) Inhalation Powder

Date of Approval: April 30, 2014
Company: GlaxoSmithKline
Treatment for: COPD, Maintenance

Incruse Ellipta (umeclidinium) is an anticholinergic bronchodilator indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

Epanova (omega-3-carboxylic acids) Capsules

Date of Approval: May 5, 2014
Company: AstraZeneca
Treatment for: Hypertriglyceridemia

Marketing Status: Discontinued

Epanova (omega-3-carboxylic acids) is a fish oil-derived mixture of free fatty acids for the treatment of patients with severe hypertriglyceridemia.

Zontivity (vorapaxar) Tablets

Date of Approval: May 8, 2014
Company: Merck
Treatment for: Cardiovascular Risk Reduction

Zontivity (vorapaxar) is a protease-activated receptor-1 (PAR-1) antagonist for the prevention of cardiovascular events in high risk patients.

Entyvio (vedolizumab) Injection

Date of Approval: May 20, 2014
Company: Takeda Pharmaceutical Company Limited
Treatment for: Crohn's Disease, Acute, Ulcerative Colitis

Entyvio (vedolizumab) is an integrin receptor antagonist for the treatment of Crohn's disease and ulcerative colitis.

Dalvance (dalbavancin) Injection

Date of Approval: May 23, 2014
Company: Allergan, Inc.
Treatment for: Skin and Structure Infection

Dalvance (dalbavancin) is a second generation lipoglycopeptide antibiotic for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Grampositive microorganisms.

Natesto (testosterone) Intranasal Gel - formerly CompleoTRT

Date of Approval: May 28, 2014
Company: Trimel Pharmaceuticals Corporation
Treatment for: Hypogonadism, Male

Natesto (testosterone) is a bioadhesive intranasal gel testosterone product for the treatment of male hypogonadism.

Omidria (ketorolac and phenylephrine) Injection

Date of Approval: May 30, 2014
Company: Omeros Corporation
Treatment for: Intraocular Lens Replacement Procedures

Omidria (ketorolac and phenylephrine) is an anti-inflammatory and mydriatic combination added to irrigation solution during cataract surgery and intraocular lens replacement procedures.

Vogelxo (testosterone) Transdermal Gel

Date of Approval: June 4, 2014
Company: Upsher-Smith Laboratories, Inc.
Treatment for: Hypogonadism, Male

Vogelxo (testosterone) transdermal gel is an androgen indicated for testosterone replacement therapy in males with hypogonadism.

Eloctate (antihemophilic factor (recombinant)) for Injection

Date of Approval: June 6, 2014
Company: Biogen Idec, Inc.
Treatment for: Hemophilia A

Eloctate (antihemophilic factor (recombinant) Fc Fusion Protein is a recombinant DNA derived, antihemophilic factor indicated for the treatment of patients with Hemophilia A.

Jublia (efinaconazole) Topical Solution

Date of Approval: June 6, 2014
Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Onychomycosis, Toenail

Jublia (efinaconazole) is a topical triazole antifungal for the treatment of onychomycosis of the toenails.

Bunavail (buprenorphine and naloxone) Buccal Film

Date of Approval: June 6, 2014
Company: BioDelivery Sciences International, Inc.
Treatment for: Opiate Dependence

Bunavail (buprenorphine and naloxone) buccal film is an opioid analgesic/opioid antagonist formulation for the maintenance treatment of opioid dependence.

Sivextro (tedizolid phosphate) Tablets and Injection

Date of Approval: June 20, 2014
Company: Cubist Pharmaceuticals, Inc.
Treatment for: Skin and Structure Infection

Sivextro (tedizolid phosphate) is an oxazolidinone antibiotic drug indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Afrezza (insulin human [rDNA origin]) Inhalation Powder - formerly Afresa

Date of Approval: June 27, 2014
Company: MannKind Corporation
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Afrezza (insulin human [rDNA origin]) is a rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus.

Vazculep (phenylephrine hydrochloride) Injection

Date of Approval: June 27, 2014
Company: Flamel Technologies
Treatment for: Hypotension

Vazculep (phenylephrine hydrochloride) injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of hypotension resulting primarily from vasodilation in the setting of anesthesia.

Beleodaq (belinostat) Injection

Date of Approval: July 3, 2014
Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Peripheral T-cell Lymphoma

Beleodaq (belinostat) is a histone deacetylase (HDAC) inhibitor for the treatment of peripheral T-cell lymphoma (PTCL).

Kerydin (tavaborole) Topical Solution

Date of Approval: July 7, 2014
Company: Anacor Pharmaceuticals
Treatment for: Onychomycosis, Toenail

Kerydin (tavaborole) is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails.

Rasuvo (methotrexate) Injection - formerly MPI-2505

Date of Approval: July 11, 2014
Company: Medac Pharma, Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Psoriasis

Rasuvo (methotrexate) is a subcutaneous, ready-to-use autopen formulation of methotrexate for the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.

Ruconest (C1 esterase inhibitor (recombinant)) - formerly Rhucin

Date of Approval: July 16, 2014
Company: Pharming Group NV
Treatment for: Hereditary Angioedema

Ruconest is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).

Zydelig (idelalisib) Tablets

Date of Approval: July 23, 2014
Company: Gilead Sciences, Inc.
Treatment for: Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma

Zydelig (idelalisib) is a phosphoinositide 3-kinase (PI3K) delta inhibitor for the treatment of chronic lymphocytic leukemia, relapsed follicular B-cell non-Hodgkin lymphoma, and relapsed small lymphocytic lymphoma.

Targiniq ER (naloxone and oxycodone) Extended-Release Tablets

Date of Approval: July 23, 2014
Company: Purdue Pharma L.P.
Treatment for: Pain

Marketing Status: Discontinued

Targiniq ER (naloxone and oxycodone) is an opioid antagonist and opioid analgesic combination in a long-acting abuse-deterrent formulation for the management of chronic severe pain.

Ryanodex (dantrolene) Injectable Suspension

Date of Approval: July 22, 2014
Company: Eagle Pharmaceuticals, Inc.
Treatment for: Malignant Hyperthermia

Ryanodex (dantrolene) is a skeletal muscle relaxant in a concentrated formulation for the treatment of malignant hyperthermia.

Flonase Allergy Relief (fluticasone propionate) Nasal Spray

Date of Approval: July 23, 2014
Company: GlaxoSmithKline plc
Treatment for: Allergic Rhinitis

Flonase Allergy Relief (fluticasone propionate) is a once-a-day, over-the-counter corticosteroid nasal spray indicated for the relief hay fever symptoms.

Acticlate (doxycycline hyclate) Tablets

Date of Approval: July 25, 2014
Company: Aqua Pharmaceuticals, LLC
Treatment for: Bacterial Infection, Acne

Acticlate (doxycycline hyclate) is a tetracycline-class antibacterial indicated for the treatment of a number of infections, including adjunctive therapy in severe acne.

Striverdi Respimat (olodaterol) Inhalation Spray

Date of Approval: July 31, 2014
Company: Boehringer Ingelheim Pharmaceuticals Inc.
Treatment for: COPD

Striverdi Respimat (olodaterol) is a once-daily, long-acting beta-agonist (LABA) for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

Jardiance (empagliflozin) Tablets

Date of Approval: August 1, 2014
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Diabetes, Type 2, Cardiovascular Risk Reduction, Heart Failure

Jardiance (empagliflozin) is a sodium glucose co-transporter-2 (SGLT2) inhibitor used for the treatment of type 2 diabetes; and to reduce the risk of cardiovascular death in patients with heart failure, and type 2 diabetes patients with established cardiovascular disease.

Orbactiv (oritavancin) Injection

Date of Approval: August 6, 2014
Company: The Medicines Company
Treatment for: Skin and Structure Infection

Orbactiv (oritavancin) is a semi-synthetic lipoglycopeptide antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Invokamet (canagliflozin and metformin) Tablets

Date of Approval: August 8, 2014
Company: Janssen Research & Development, LLC
Treatment for: Diabetes, Type 2, Cardiovascular Risk Reduction

Invokamet (canagliflozin/metformin) is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor and biguanide combination indicated for the treatment of type 2 diabetes, and to reduce the risk of cardiovascular events (including heart attack, stroke or death) in adults with type 2 diabetes and established cardiovascular disease.

Belsomra (suvorexant) Tablets

Date of Approval: August 13, 2014
Company: Merck, Sharpe & Dohme Corp.
Treatment for: Insomnia

Belsomra (suvorexant) is an orexin receptor antagonist for use in patients with difficulty falling or staying asleep (insomnia).

Plegridy (peginterferon beta-1a) Injection

Date of Approval: August 15, 2014
Company: Biogen Idec
Treatment for: Multiple Sclerosis

Plegridy (peginterferon beta-1a) is a pegylated interferon beta indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Cerdelga (eliglustat) Capsules

Date of Approval: August 19, 2014
Company: Genzyme Corporation
Treatment for: Gaucher Disease

Cerdelga (eliglustat) is a glucosylceramide synthase inhibitor indicated for the long- term treatment of adult patients with Gaucher disease type 1.

Arnuity Ellipta (fluticasone furoate) Inhalation Powder

Date of Approval: August 20, 2014
Company: GlaxoSmithKline plc
Treatment for: Asthma, Asthma, Maintenance

Arnuity Ellipta (fluticasone furoate inhalation powder) is a once-daily inhaled corticosteroid for the maintenance treatment of asthma.

Triumeq (abacavir, dolutegravir and lamivudine) Tablets

Date of Approval: August 22, 2014
Company: ViiV Healthcare
Treatment for: HIV Infection

Triumeq (abacavir, dolutegravir and lamivudine) is a fixed-dose combination containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine for the treatment of HIV-1 infection.

Kabiven (amino acids, electrolytes, dextrose and lipid) Injectable Emulsion

Date of Approval: August 25, 2014
Company: Fresenius Kabi USA
Treatment for: Parenteral Nutrition

Kabiven (amino acids, electrolytes, dextrose and lipid injectable emulsion) is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition.

Keytruda (pembrolizumab) for Injection

Date of Approval: September 4, 2014
Company: Merck & Co., Inc.
Treatment for: Melanoma, Metastatic, Non-Small Cell Lung Cancer, Head and Neck Cancer, Hodgkin's Lymphoma, Urothelial Carcinoma, Gastric Cancer, Cervical Cancer, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Renal Cell Carcinoma, Esophageal Carcinoma, Endometrial Cancer, Squamous Cell Carcinoma, Hepatocellular Carcinoma, Breast Cancer

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer, microsatellite instability-high or mismatch repair deficient colorectal cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma, and triple-negative breast cancer.

Auryxia (ferric citrate) Tablets

Date of Approval: September 5, 2014
Company: Keryx Biopharmaceuticals, Inc.
Treatment for: Hyperphosphatemia of Renal Failure, Anemia Associated with Chronic Renal Failure

Auryxia (ferric citrate) is a phosphate binder indicated for the control of serum phosphorus levels in dialysis patients; and an iron replacement product for the treatment of iron deficiency anemia in adult patients with chronic kidney disease who are not on dialysis.

Contrave (bupropion and naltrexone) Tablets

Date of Approval: September 10, 2014
Company: Orexigen Therapeutics, Inc.
Treatment for: Obesity

Contrave (bupropion/naltrexone) is an aminoketone antidepressant and opioid antagonist combination indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management.

Movantik (naloxegol) Tablets

Date of Approval: September 16, 2014
Company: AstraZeneca Pharmaceuticals LP
Treatment for: Opioid-Induced Constipation

Movantik (naloxegol) is a peripherally-acting mu-opioid receptor antagonist indicated for the treatment of opioid-induced constipation.

Trulicity (dulaglutide) Injection

Date of Approval: September 18, 2014
Company: Eli Lilly and Company
Treatment for: Diabetes, Type 2, Cardiovascular Risk Reduction

Trulicity (dulaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.

Vitekta (elvitegravir) Tablets

Date of Approval: September 24, 2014
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Marketing Status: Discontinued

Vitekta (elvitegravir) is an integrase inhibitor for the combination treatment of HIV-1 infection in treatment-experienced adults.

Tybost (cobicistat) Tablets

Date of Approval: September 24, 2014
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Tybost (cobicistat) is a potent inhibitor of cytochrome P450 3A (CYP3A) which acts as a pharmacoenhancing or "boosting" agent for antiviral drugs used in the treatment of HIV infection.

Iluvien (fluocinolone acetonide) Intravitreal Implant

Date of Approval: September 26, 2014
Company: pSivida Corp.
Treatment for: Diabetic Macular Edema

Iluvien (fluocinolone acetonide) is an intravitreal implant for the treatment of diabetic macular edema.

Akynzeo (netupitant and palonosetron) Capsules

Date of Approval: October 10, 2014
Company: Helsinn Group
Treatment for: Nausea/Vomiting, Chemotherapy Induced

Akynzeo (netupitant and palonosetron) is a substance P/neurokinin 1 (NK1) receptor antagonist and serotonin-3 (5-HT3) receptor antagonist fixed-dose combination indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Harvoni (ledipasvir and sofosbuvir) Tablets and Oral Pellets

Date of Approval: October 10, 2014
Company: Gilead Sciences, Inc.
Treatment for: Hepatitis C

Harvoni (ledipasvir and sofosbuvir) is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, indicated for the treatment of chronic hepatitis C virus (HCV) in adults and pediatric patients 3 years of age and older:

  • genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
  • genotype 1 infection with decompensated cirrhosis, in combination with ribavirin
  • genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin.

Lumason (sulfur hexafluoride lipid microsphere) Injectable Suspension

Date of Approval: October 10, 2014
Company: Bracco Diagnostics Inc.
Treatment for: Diagnosis and Investigation

Lumason (sulfur hexafluoride lipid microsphere) is a contrast agent used for ultrasound imaging.

Esbriet (pirfenidone) Capsules

Date of Approval: October 15, 2014
Company: InterMune, Inc.
Treatment for: Idiopathic Pulmonary Fibrosis

Esbriet (pirfenidone) is a TGF-beta synthesis inhibitor for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

Ofev (nintedanib) Capsules

Date of Approval: October 15, 2014
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease

Ofev (nintedanib) is a small molecule tyrosine kinase inhibitor (TKI) indicated for:

  • treatment of idiopathic pulmonary fibrosis (IPF).
  • treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.
  • slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Sotylize (sotalol hydrochloride) Oral Solution

Date of Approval: October 22, 2014
Company: Arbor Pharmaceuticals
Treatment for: Ventricular Arrhythmia, Atrial Fibrillation, Atrial Flutter

Sotylize (sotalol hydrochloride) is an antiarrhythmic indicated for the treatment of ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with history of highly symptomatic atrial fibrillation/flutter.

Obizur (antihemophilic factor (recombinant))

Date of Approval: October 23, 2014
Company: Baxter International Inc.
Treatment for: Hemophilia A

Obizur (antihemophilic factor [recombinant]) is an antihemophilic factor indicated for the treatment of bleeding episodes in adults with acquired hemophilia A.

Trumenba (meningococcal group B vaccine)

Date of Approval: October 29, 2014
Company: Pfizer Inc.
Treatment for: Meningococcal Meningitis Prophylaxis

Trumenba (meningococcal group B vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in adolescents and young adults.

Xigduo XR (dapagliflozin and metformin hydrochloride) Extended-Release Tablets

Date of Approval: October 30, 2014
Company: AstraZeneca
Treatment for: Diabetes, Type 2

Xigduo XR (dapagliflozin and metformin hydrochloride) is a once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor and biguanide combination for the treatment of type 2 diabetes.

Lemtrada (alemtuzumab) Injection

Date of Approval: November 14, 2014
Company: Genzyme
Treatment for: Multiple Sclerosis

Lemtrada (alemtuzumab) is a CD52-directed cytolytic monoclonal antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS).

Hysingla ER (hydrocodone bitartrate) Extended-Release Tablets

Date of Approval: November 20, 2014
Company: Purdue Pharma L.P.
Treatment for: Chronic Pain

Hysingla ER (hydrocodone) is a single-entity (without acetaminophen) extended-release opioid analgesic for around-the-clock management of moderate to severe chronic pain.

Onexton (benzoyl peroxide and clindamycin phosphate) Gel

Date of Approval: November 25, 2014
Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Acne

Onexton (benzoyl peroxide and clindamycin phosphate) is an antimicrobial and lincosamide antibacterial combination for the once-daily topical treatment of acne vulgaris.

Kitabis Pak (tobramycin) Inhalation Solution

Date of Approval: December 2, 2014
Company: PulmoFlow, Inc.
Treatment for: Cystic Fibrosis

Kitabis Pak (tobramycin) is an aminoglycoside inhalation solution co-packaged with a PARI LC PLUS® Reusable Nebulizer for the management of cystic fibrosis.

Blincyto (blinatumomab) Injection

Date of Approval: December 3, 2014
Company: Amgen Inc.
Treatment for: Acute Lymphoblastic Leukemia

Blincyto (blinatumomab) is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), and minimal residual disease (MRD)-positive B-cell precursor ALL.

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) Injection

Date of Approval: December 10, 2014
Company: Merck & Co., Inc.
Treatment for: Human Papillomavirus Prophylaxis

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) is a 9-valent HPV vaccine indicated for use in:

  • girls and women 9 through 45 years of age for the prevention of:
    • cervical, vulvar, vaginal, oropharyngeal and other head and neck cancers caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58.
    • genital warts (condyloma acuminata) caused by HPV types 6 and 11
    • precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
  • boys and men 9 through 45 years for the prevention of:
    • anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
    • genital warts (condyloma acuminata) caused by HPV types 6 and 11
    • precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58

Signifor LAR (pasireotide) for Injectable Suspension

Date of Approval: December 15, 2014
Company: Novartis
Treatment for: Acromegaly

Signifor LAR (pasireotide) is a long acting a somatostatin analog formulation for the treatment of patients with acromegaly.

Xtoro (finafloxacin) Otic Suspension

Date of Approval: December 17, 2014
Company: Alcon Laboratories, Inc.
Treatment for: Otitis Externa

Marketing Status: Discontinued

Xtoro (finafloxacin otic suspension) is a fluoroquinolone antimicrobial for the treatment of acute otitis externa, commonly known as swimmer’s ear.

Lynparza (olaparib) Tablets

Date of Approval: December 19, 2014
Company: AstraZeneca
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Breast Cancer, Pancreatic Cancer, Prostate Cancer

Lynparza (olaparib) is a first-in-class oral poly ADP ribose polymerase (PARP) inhibitor indicated for the treatment of ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.

Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir) Tablets

Date of Approval: December 19, 2014
Company: AbbVie Inc.
Treatment for: Hepatitis C

Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir) is an NS5A inhibitor, NS3/4A protease inhibitor and CYP3A inhibitor combination co-packaged with a non-nucleoside NS5B palm polymerase inhibitor for the treatment of patients with genotype 1 chronic hepatitis C virus (HCV) infection.

Zerbaxa (ceftolozane and tazobactam) Injection

Date of Approval: December 19, 2014
Company: Cubist Pharmaceuticals, Inc.
Treatment for: Intraabdominal Infection, Urinary Tract Infection, Pneumonia

Zerbaxa (ceftolozane and tazobactam) is a cephalosporin and beta-lactamase inhibitor combination for the treatment of:

  • complicated intra-abdominal Infections (cIAI), used in combination with metronidazole
  • complicated urinary tract infections (cUTI), including pyelonephritis
  • hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

Opdivo (nivolumab) Injection

Date of Approval: December 22, 2014
Company: Bristol-Myers Squibb Company
Treatment for: Melanoma, Metastatic, Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Hodgkin's Lymphoma, Head and Neck Cancer, Urothelial Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Esophageal Carcinoma, Malignant Pleural Mesothelioma, Gastric Cancer

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, esophageal cancer, gastric cancer, and gastroesophageal junction cancer.

Rapivab (peramivir) Injection

Date of Approval: December 19, 2014
Company: BioCryst Pharmaceuticals, Inc.
Treatment for: Influenza

Rapivab (peramivir) is an influenza virus neuraminidase inhibitor indicated for the treatment of acute uncomplicated influenza.

Soolantra (ivermectin) Cream

Date of Approval: December 19, 2014
Company: Galderma Laboratories, L.P.
Treatment for: Rosacea

Soolantra (ivermectin) is a topical antiparasitic with anti-inflammatory properties for the treatment of rosacea potentially caused by the microscopic skin mite Demodex folliculorum.

Saxenda (liraglutide) Injection

Date of Approval: December 23, 2014
Company: Novo Nordisk Inc.
Treatment for: Obesity

Saxenda (liraglutide) is a once-daily glucagon-like peptide-1 (GLP-1) analogue for the treatment of obesity.

Namzaric (donepezil and memantine)

Date of Approval: December 23, 2014
Company: Allergan, Inc.
Treatment for: Alzheimer's Disease

Namzaric (memantine hydrochloride extended-release and donepezil hydrochloride) is an NMDA receptor antagonist and acetylcholinesterase inhibitor fixed-dose combination for the treatment of moderate to severe Alzheimer’s disease.

Dyloject (diclofenac sodium) Injection

Date of Approval: December 23, 2014
Company: Pfizer Inc.
Treatment for: Pain

Marketing Status: Discontinued

Dyloject (diclofenac sodium injection) is an intravenous non-steroidal anti-inflammatory drug (NSAID) for the management of acute moderate-to-severe pain in adults.

Opdivo (nivolumab) Injection

Date of Approval: December 22, 2014
Company: Bristol-Myers Squibb Company
Treatment for: Melanoma, Metastatic, Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Hodgkin's Lymphoma, Head and Neck Cancer, Urothelial Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Esophageal Carcinoma, Malignant Pleural Mesothelioma, Gastric Cancer

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, esophageal cancer, gastric cancer, and gastroesophageal junction cancer.

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