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New Drug Approvals Archive for 2013

See also: New Indications and Dosage Forms for 2013

FluLaval Quadrivalent (influenza virus vaccine, inactivated)

Date of Approval: August 16, 2013
Company: GlaxoSmithKline
Treatment for: Influenza Prophylaxis

FluLaval Quadrivalent is an inactivated influenza virus vaccine indicated for active immunization against influenza disease in people aged 6 months and older.

Skyla (levonorgestrel) Intrauterine System

Date of Approval: January 9, 2013
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Birth Control

Skyla (levonorgestrel) is a progestin-containing intrauterine system (IUS) indicated for prevention of pregnancy for up to three years.

Uceris (budesonide)

Date of Approval: January 14, 2013
Company: Santarus, Inc.
Treatment for: Ulcerative Colitis

Uceris (budesonide) is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.

Octaplas (pooled plasma (human)) Solution for Intravenous Infusion

Date of Approval: January 17, 2013
Company: Octapharma
Treatment for: Bleeding Disorder

Octaplas is a solvent/detergent (S/D) treated, pooled human plasma indicated for the replacement of multiple coagulation factors in patients with acquired deficiencies and plasma exchange in patients with thrombotic thrombocytopenic purpura.

Zecuity (sumatriptan) Transdermal Patch

Date of Approval: January 17, 2013
Company: NuPathe Inc.
Treatment for: Migraine

Marketing Status: Discontinued

Zecuity (sumatriptan iontophoretic transdermal system) is a serotonin (5HT) 1b/1d receptor agonist (triptan) indicated for the acute treatment of migraine.

Oxytrol for Women (oxybutynin) Transdermal System

Date of Approval: January 25, 2013
Company: Merck
Treatment for: Overactive Bladder

Oxytrol for Women (oxybutynin) is a muscarinic receptor antagonist transdermal patch available over-the-counter for the treatment of overactive bladder in women.

Nesina (alogliptin) Tablets - formerly SYR-322

Date of Approval: January 25, 2013
Company: Takeda Pharmaceutical Company Limited
Treatment for: Diabetes, Type 2

Nesina (alogliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment of type 2 diabetes.

Oseni (alogliptin and pioglitazone) Tablets - formerly SYR-322/Actos

Date of Approval: January 25, 2013
Company: Takeda Pharmaceutical Company Limited
Treatment for: Diabetes, Type 2

Oseni (alogliptin and pioglitazone) is a dipeptidyl peptidase-4 (DPP-4) inhibitor and thiazolidinedione fixed-dose combination for the treatment of type 2 diabetes.

Kazano (alogliptin and metformin) Tablets

Date of Approval: January 25, 2013
Company: Takeda Pharmaceutical Company Limited
Treatment for: Diabetes, Type 2

Kazano (alogliptin and metformin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide antihyperglycemic fixed-dose combination for the treatment of type 2 diabetes.

Kynamro (mipomersen) Injection

Date of Approval: January 29, 2013
Company: Kastle Therapeutics
Treatment for: High Cholesterol, Familial Homozygous

Marketing Status: Discontinued

Kynamro (mipomersen) is an oligonucleotide inhibitor of apolipoprotein B-100 synthesis indicated for the treatment of patients with homozygous familial hypercholesterolemia.

Ravicti (glycerol phenylbutyrate) Oral Liquid

Date of Approval: February 1, 2013
Company: Hyperion Therapeutics
Treatment for: Urea Cycle Disorders

Ravicti (glycerol phenylbutyrate) is a nitrogen-binding agent for the chronic management of patients with urea cycle disorders.

Delzicol (mesalamine) Delayed-Release Capsules

Date of Approval: February 1, 2013
Company: Allergan, Inc.
Treatment for: Ulcerative Colitis

Delzicol (mesalamine) is an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.

Pomalyst (pomalidomide) Capsules

Date of Approval: February 8, 2013
Company: Bristol Myers Squibb
Treatment for: Multiple Myeloma, Kaposi's Sarcoma

Pomalyst (pomalidomide) is a thalidomide analogue used for the treatment of multiple myeloma, and AIDS-related and HIV-negative Kaposi sarcoma.

Kadcyla (ado-trastuzumab emtansine) Injection

Date of Approval: February 22, 2013
Company: Genentech, Inc.
Treatment for: Breast Cancer

Kadcyla (ado-trastuzumab emtansine) is a HER2-targeted antibody and microtubule inhibitor conjugate indicated for the treatment of patients with HER2-positive, metastatic breast cancer.

Osphena (ospemifene) Tablets

Date of Approval: February 26, 2013
Company: Duchesnay Inc.
Treatment for: Dyspareunia, Atrophic Vaginitis

Osphena (ospemifene) is an estrogen agonist/antagonist indicated for the treatment of symptoms of vulvar and vaginal atrophy due to menopause, including severe dyspareunia and moderate to severe vaginal dryness.

Vituz (chlorpheniramine and hydrocodone) Oral Solution

Date of Approval: February 20, 2013
Company: Hawthorn Pharmaceuticals, Inc.
Treatment for: Cough, Cold Symptoms

Vituz (chlorpheniramine and hydrocodone) Oral Solution is an antihistamine/antitussive combination indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold.

Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension

Date of Approval: February 28, 2013
Company: Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S
Treatment for: Schizophrenia, Bipolar Disorder

Abilify Maintena (aripiprazole) is an atypical antipsychotic indicated for the treatment of schizophrenia, and maintenance monotherapy treatment of bipolar I disorder.

Lymphoseek (technetium Tc 99m tilmanocept) Injection

Date of Approval: March 13, 2013
Company: Navidea Biopharmaceuticals
Treatment for: Diagnosis and Investigation

Lymphoseek (technetium Tc 99m tilmanocept) Injection is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:
  • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management.
  • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

Dotarem (gadoterate meglumine) Injection

Date of Approval: March 20, 2013
Company: Guerbet
Treatment for: Diagnosis and Investigation

Dotarem (gadoterate meglumine) is a gadolinium-based contrast agent indicated for use in magnetic resonance imaging (MRI).

TOBI Podhaler (tobramycin) Inhalation Powder

Date of Approval: March 22, 2013
Company: Novartis Pharmaceuticals Corporation
Treatment for: Cystic Fibrosis

TOBI Podhaler (tobramycin inhalation powder) is an antibacterial aminoglycoside indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.

Tecfidera (dimethyl fumarate) Delayed-Release Capsules - formerly BG-12

Date of Approval: March 27, 2013
Company: Biogen Idec
Treatment for: Multiple Sclerosis

Tecfidera (dimethyl fumarate) is an oral Nrf2 pathway activator for the treatment of relapsing forms of multiple sclerosis.

Invokana (canagliflozin) Tablets

Date of Approval: March 29, 2013
Company: Janssen Research & Development, LLC
Treatment for: Diabetes, Type 2, Cardiovascular Risk Reduction, Diabetic Kidney Disease

Invokana (canagliflozin) is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor indicated:

  • along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes
  • to reduce the risk of major cardiovascular events in adults with type 2 diabetes who have known cardiovascular disease
  • to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine.

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets

Date of Approval: March 28, 2013
Company: Teva Branded Pharmaceutical Products R&D, Inc.
Treatment for: Birth Control

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) is a 91-day extended regimen oral contraceptive indicated for the prevention of pregnancy.

Karbinal ER (carbinoxamine) Extended-Release Oral Suspension

Date of Approval: March 28, 2013
Company: Tris Pharma, Inc.
Treatment for: Conjunctivitis, Allergic, Allergic Reactions, Allergic Rhinitis, Allergic Urticaria

Karbinal ER (carbinoxamine maleate) extended-release oral suspension is an H1 receptor antagonist indicated for the symptomatic treatment of seasonal and perennial allergic rhinitis.

Prolensa (bromfenac) Ophthalmic Solution

Date of Approval: April 5, 2013
Company: Bausch + Lomb
Treatment for: Postoperative Ocular Inflammation

Prolensa (bromfenac ophthalmic solution) is a topical nonsteroidal anti-inflammatory indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

Diclegis (doxylamine and pyridoxine) Delayed-Release Tablets

Date of Approval: April 8, 2013
Company: Duchesnay Inc.
Treatment for: Nausea and Vomiting of Pregnancy

Diclegis (doxylamine and pyridoxine) is an antihistamine and vitamin B6 analog combination indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

Sitavig (acyclovir) Buccal Tablets

Date of Approval: April 12, 2013
Company: BioAlliance Pharma SA
Treatment for: Cold Sores

Sitavig (acyclovir) is a mucoadhesive buccal tablet formulation of the antiviral drug acyclovir indicated for the treatment of recurrent orofacial herpes (cold sores).

Simbrinza (brimonidine and brinzolamide) Ophthalmic Suspension

Date of Approval: April 19, 2013
Company: Alcon
Treatment for: Glaucoma

Simbrinza (brimonidine and brinzolamide) is a fixed combination of an alpha 2 adrenergic receptor agonist and a carbonic anhydrase inhibitor indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Kcentra (prothrombin complex concentrate, human)

Date of Approval: April 29, 2013
Company: CSL Behring
Treatment for: Reversal of Vitamin K Antagonist (VKA) Anticoagulation

Procysbi (cysteamine bitartrate) Delayed-Release Capsules

Date of Approval: April 30, 2013
Company: Raptor Pharmaceutical Corp.
Treatment for: Nephropathic Cystinosis

Procysbi (cysteamine bitartrate) is a cystine depleting agent indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older.

Liptruzet (atorvastatin and ezetimibe) Tablets

Date of Approval: May 3, 2013
Company: Merck
Treatment for: High Cholesterol, Familial Heterozygous

Marketing Status: Discontinued

Liptruzet (atorvastatin and ezetimibe) is a statin (HMG-CoA reductase inhibitor) and cholesterol absorption inhibitor combination indicated for the treatment of hyperlipidemia.

Breo Ellipta (fluticasone and vilanterol) Inhalation Powder

Date of Approval: May 10, 2013
Company: GlaxoSmithKline plc (GSK) and Theravance, Inc.
Treatment for: COPD, Asthma

Breo Ellipta (fluticasone and vilanterol) is a once-a-day inhaled corticosteroid/long-acting beta2 agonist (LABA) combination indicated for the treatment of patients with chronic obstructive pulmonary disease (COPD) and asthma.

Nymalize (nimodipine) Oral Solution

Date of Approval: May 10, 2013
Company: Arbor Pharmaceuticals
Treatment for: Subarachnoid Hemorrhage

Nymalize (nimodipine) is a calcium channel blocker indicated to improve neurological outcome following subarachnoid hemorrhage.

Xofigo (radium Ra 223 dichloride) Injection

Date of Approval: May 15, 2013
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Prostate Cancer

Xofigo (radium 223 dichloride) is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer.

Tafinlar (dabrafenib) Capsules

Date of Approval: May 29, 2013
Company: GlaxoSmithKline
Treatment for: Melanoma, Metastatic, Non-Small Cell Lung Cancer, Thyroid Cancer, Solid Tumors

Tafinlar (dabrafenib) is a kinase inhibitor for the treatment of melanoma, non-small cell lung cancer, thyroid cancer, and solid tumors with BRAF V600 mutations.

Mekinist (trametinib) Tablets

Date of Approval: May 29, 2013
Company: GlaxoSmithKline
Treatment for: Melanoma, Metastatic, Non-Small Cell Lung Cancer, Thyroid Cancer, Solid Tumors

Mekinist (trametinib) is a kinase inhibitor for the treatment of melanoma, non-small cell lung cancer, thyroid cancer, and solid tumors with BRAF V600 mutations.

Bloxiverz (neostigmine methylsulfate) Injection

Date of Approval: May 31, 2013
Company: Flamel Technologies
Treatment for: Reversal of Nondepolarizing Muscle Relaxants

Bloxiverz (neostigmine methylsulfate) is a cholinesterase inhibitor used for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.

Rixubis (coagulation factor IX (recombinant)) Injection

Date of Approval: June 26, 2013
Company: Baxter International Inc.
Treatment for: Hemophilia B

Rixubis (coagulation factor IX, recombinant) is an antihemophilic factor indicated for the control and prevention of bleeding episodes in adults with hemophilia B.

Brisdelle (paroxetine mesylate) Capsules

Date of Approval: June 28, 2013
Company: Noven Pharmaceuticals, Inc.
Treatment for: Hot Flashes Associated with Menopause

Brisdelle (paroxetine mesylate) is a low-dose selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause.

Zubsolv (buprenorphine and naloxone) Sublingual Tablets

Date of Approval: July 3, 2013
Company: Orexo AB
Treatment for: Opiate Dependence

Zubsolv (buprenorphine and naloxone) is a sublingual partial opioid agonist indicated for the maintenance treatment of opioid dependence.

Khedezla (desvenlafaxine) Extended-Release Tablets

Date of Approval: July 10, 2013
Company: Osmotica Pharmaceutical Corp.
Treatment for: Depression

Khedezla (desvenlafaxine) is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder.

Gilotrif (afatinib) Tablets

Date of Approval: July 12, 2013
Company: Boehringer Ingelheim Pharmaceuticals Inc.
Treatment for: Non-Small Cell Lung Cancer

Gilotrif (afatinib) is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC).

Simponi Aria (golimumab) Injection

Date of Approval: July 18, 2013
Company: Janssen Biotech, Inc.

Simponi Aria (golimumab) is a tumor necrosis factor (TNF) blocker indicated for the treatment of:

  • Adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate
  • Active Psoriatic Arthritis (PsA) in patients 2 years of age and older
  • Adult patients with active Ankylosing Spondylitis (AS)
  • Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older

Astagraf XL (tacrolimus) Extended-Release Capsules

Date of Approval: July 19, 2013
Company: Astellas Pharma US, Inc.
Treatment for: Organ Transplant, Rejection Prophylaxis

Astagraf XL (tacrolimus) is a calcineurin-inhibitor immunosuppressant for the prophylaxis of organ rejection in patients receiving a kidney transplant.

Lo Minastrin Fe (ethinyl estradiol and norethindrone, ethinyl estradiol, and ferrous fumarate) Tablets

Date of Approval: July 24, 2013
Company: Warner Chilcott plc
Treatment for: Birth Control

Marketing Status: Discontinued

Lo Minastrin Fe (ethinyl estradiol and norethindrone, ethinyl estradiol, and ferrous fumarate) is an estrogen/progestin combined oral contraceptive indicated for use by women to prevent pregnancy.

Injectafer (ferric carboxymaltose) Injection

Date of Approval: July 25, 2013
Company: Luitpold Pharmaceuticals, Inc.
Treatment for: Iron Deficiency Anemia

Injectafer (ferric carboxymaltose) is an iron replacement product indicated for the treatment of iron deficiency anemia.

Fetzima (levomilnacipran) Extended-Release Capsules

Date of Approval: July 25, 2013
Company: Allergan, Inc.
Treatment for: Depression

Fetzima (levomilnacipran) is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder.

Tivicay (dolutegravir) Tablets

Date of Approval: August 12, 2013
Company: ViiV Healthcare
Treatment for: HIV Infection

Tivicay (dolutegravir) is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated for use in combination with other antiretroviral (ARV) agents for the treatment of HIV-1.

Epaned (enalapril maleate) Oral Solution

Date of Approval: August 13, 2013
Company: Silvergate Pharmaceuticals Inc.
Treatment for: High Blood Pressure, Heart Failure, Left Ventricular Dysfunction

Epaned (enalapril maleate) is an angiotensin-converting enzyme inhibitor indicated for the treatment of hypertension in adults and children older than one month, symptomatic heart failure, and asymptomatic left ventricular dysfunction.

FluLaval Quadrivalent (influenza virus vaccine, inactivated)

Date of Approval: August 16, 2013
Company: GlaxoSmithKline
Treatment for: Influenza Prophylaxis

FluLaval Quadrivalent is an inactivated influenza virus vaccine indicated for active immunization against influenza disease in people aged 6 months and older.

Trokendi XR (topiramate)

Date of Approval: August 16, 2013
Company: Supernus Pharmaceuticals, Inc.
Treatment for: Epilepsy

Trokendi XR (topiramate) is an antiepileptic drug indicated for the treatment of epilepsy.

Valchlor (mechlorethamine) Topical Gel

Date of Approval: August 23, 2013
Company: Ceptaris Therapeutics, Inc.
Treatment for: Mycosis Fungoides

Valchlor (mechlorethamine) gel an alkylating agent indicated for the topical treatment of Stage IA and IB mycosis fungoides‐type cutaneous T‐cell lymphoma.

Mirvaso (brimonidine) Topical Gel

Date of Approval: August 23, 2013
Company: Galderma Laboratories, L.P.
Treatment for: Rosacea

Mirvaso (brimonidine) topical gel is an alpha adrenergic agonist indicated for the topical treatment of facial erythema of rosacea.

Trintellix (vortioxetine) Tablets - formerly Brintellix

Date of Approval: September 30, 2013
Company: Takeda Pharmaceutical Company Limited and H. Lundbeck A/S
Treatment for: Depression

Trintellix (vortioxetine) is a multimodal antidepressant for the treatment of major depressive disorder (MDD).

Duavee (bazedoxifene and conjugated estrogens) Tablets

Date of Approval: October 3, 2013
Company: Pfizer Inc.
Treatment for: Postmenopausal Symptoms, Prevention of Osteoporosis

Duavee (bazedoxifene and conjugated estrogens) is an estrogen agonist/antagonist and conjugated estrogens combination indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause, and prevention of postmenopausal osteoporosis in women with an intact uterus.

Clinolipid (lipid injectable emulsion)

Date of Approval: October 3, 2013
Company: Baxter Healthcare Corporation
Treatment for: Parenteral Nutrition

Marketing Status: Discontinued

Clinolipid (lipid injectable emulsion) is an intravenous fat supplement indicated for parenteral nutrition.

Adempas (riociguat) Tablets

Date of Approval: October 8, 2013
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Pulmonary Hypertension

Adempas (riociguat) is an oral soluble guanylate cyclase (sGC) stimulator for the treatment of pulmonary hypertension.

Otrexup (methotrexate) Subcutaneous Injection

Date of Approval: October 11, 2013
Company: Antares Pharma, Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriasis

Otrexup (methotrexate) is a folate analog metabolic inhibitor self-administered once weekly for use in the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriasis.

Novoeight (turoctocog alfa) for Intravenous Injection

Date of Approval: October 15, 2013
Company: Novo Nordisk
Treatment for: Hemophilia A

Novoeight (turoctocog alfa) is an antihemophilic factor (recombinant) indicated for use in adults and children with hemophilia A.

Zorvolex (diclofenac) Capsules

Date of Approval: October 18, 2013
Company: Iroko Pharmaceuticals, LLC
Treatment for: Pain, Osteoarthritis

Zorvolex (diclofenac) is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of mild to moderate acute pain, and for the management of osteoarthritis pain.

Opsumit (macitentan) Tablets

Date of Approval: October 18, 2013
Company: Actelion Pharmaceuticals Ltd.
Treatment for: Pulmonary Hypertension

Opsumit (macitentan) is a dual endothelin receptor antagonist for the treatment of patients with pulmonary arterial hypertension.

Zohydro ER (hydrocodone) Extended-Release Capsules

Date of Approval: October 25, 2013
Company: Zogenix, Inc.
Treatment for: Pain

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

Vizamyl (flutemetamol F 18) Injection

Date of Approval: October 25, 2013
Company: GE Healthcare
Treatment for: Diagnosis and Investigation

Vizamyl (flutemetamol F 18) is a PET amyloid imaging agent for the evaluation of Alzheimer's disease or other cognitive disorders.

Gazyva (obinutuzumab) Injection

Date of Approval: November 1, 2013
Company: Genentech
Treatment for: Chronic Lymphocytic Leukemia, Follicular Lymphoma

Gazyva (obinutuzumab) is a CD20-directed cytolytic antibody indicated for the combination treatment of patients with chronic lymphocytic leukemia and follicular lymphoma.

Aptiom (eslicarbazepine acetate) Tablets - formerly Stedesa

Date of Approval: November 8, 2013
Company: Sunovion Pharmaceuticals Inc.
Treatment for: Epilepsy, Seizures

Aptiom (eslicarbazepine acetate) is a voltage-gated sodium channel blocker for the treatment of partial-onset seizures in patients with epilepsy.

Imbruvica (ibrutinib) Capsules and Tablets

Date of Approval: November 13, 2013
Company: AbbVie Inc.
Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenström’s Macroglobulinemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma; Chronic Graft Versus Host Disease

Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with:

  • Mantle cell lymphoma (MCL) who have received at least one prior therapy.
    Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)
  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.
  • Waldenström’s macroglobulinemia (WM).
  • Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
    Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.

Luzu (luliconazole) Topical Cream

Date of Approval: November 14, 2013
Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Tinea Corporis, Tinea Pedis, Tinea Cruris

Luzu (luliconazole) Cream is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis.

Olysio (simeprevir) Capsules

Date of Approval: November 22, 2013
Company: Janssen Research & Development, LLC
Treatment for: Hepatitis C

Olysio (simeprevir) is a protease inhibitor for the treatment of chronic hepatitis C virus infection.

Varithena (polidocanol) Injectable Foam

Date of Approval: November 25, 2013
Company: BTG plc
Treatment for: Varicose Veins

Varithena (polidocanol) injectable foam is a sclerosing agent indicated for the treatment of varicose veins.

Velphoro (sucroferric oxyhydroxide) Chewable Tablets

Date of Approval: November 27, 2013
Company: Vifor Fresenius Medical Care Renal Pharma
Treatment for: Hyperphosphatemia of Renal Failure

Velphoro (sucroferric oxyhydroxide) is a chewable, iron-based phosphate binder for the control of serum phosphorus levels in patients with Chronic Kidney Disease (CKD) on dialysis.

Sovaldi (sofosbuvir) Tablets and Oral Pellets

Date of Approval: December 6, 2013
Company: Gilead Sciences
Treatment for: Hepatitis C

Sovaldi (sofosbuvir) is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of:

  • adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen.
  • pediatric patients 3 years of age and older with genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis in combination with ribavirin.

Anoro Ellipta (umeclidinium bromide and vilanterol)

Date of Approval: December 18, 2013
Company: GlaxoSmithKline plc (GSK) and Theravance, Inc.
Treatment for: COPD

Anoro Ellipta (umeclidinium bromide and vilanterol) is a long-acting muscarinic antagonist (LAMA) and long-acting beta2 agonist (LABA) combination for the treatment of COPD.

Tretten (coagulation factor XIII A-subunit (recombinant))

Date of Approval: December 23, 2013
Company: Novo Nordisk A/S
Treatment for: Factor XIII A-Subunit Deficiency

Tretten (coagulation factor XIII A-subunit (recombinant)) is a recombinant analogue of the human Factor XIII A-subunit for the prevention of bleeding in patients who have the rare clotting disorder congenital Factor XIII A-subunit deficiency.

Orenitram (treprostinil) Extended-Release Tablets

Date of Approval: December 20, 2013
Company: United Therapeutics Corporation
Treatment for: Pulmonary Hypertension

Orenitram (treprostinil extended-release) is an oral prostacyclin for the treatment of pulmonary arterial hypertension.

Epaned (enalapril maleate) Oral Solution

Date of Approval: August 13, 2013
Company: Silvergate Pharmaceuticals Inc.
Treatment for: High Blood Pressure, Heart Failure, Left Ventricular Dysfunction

Epaned (enalapril maleate) is an angiotensin-converting enzyme inhibitor indicated for the treatment of hypertension in adults and children older than one month, symptomatic heart failure, and asymptomatic left ventricular dysfunction.

Zubsolv (buprenorphine and naloxone) Sublingual Tablets

Date of Approval: July 3, 2013
Company: Orexo AB
Treatment for: Opiate Dependence

Zubsolv (buprenorphine and naloxone) is a sublingual partial opioid agonist indicated for the maintenance treatment of opioid dependence.

Epaned (enalapril maleate) Oral Solution

Date of Approval: August 13, 2013
Company: Silvergate Pharmaceuticals Inc.
Treatment for: High Blood Pressure, Heart Failure, Left Ventricular Dysfunction

Epaned (enalapril maleate) is an angiotensin-converting enzyme inhibitor indicated for the treatment of hypertension in adults and children older than one month, symptomatic heart failure, and asymptomatic left ventricular dysfunction.

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