NAMZARIC

  • 8/2/2015
  • Actavis
  • Memantine HCl extended-release, donepezil HCl; 14mg/10mg, 28mg/10mg; capsules.
  • Moderate-to-severe dementia of the Alzheimer's type in patients stabilized on memantine HCl and donepezil HCl.
STIOLTO RESPIMAT

STIOLTO RESPIMAT

  • 7/26/2015
  • Boehringer Ingelheim Pharmaceuticals
  • Tiotropium 2.5mcg, olodaterol 2.5mcg; per actuation; inhalation spray; contains benzalkonium chloride.
  • Long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Limitations of use: not for treating asthma or acute deteriorations of COPD.

EVEKEO

  • 7/19/2015
  • Arbor Pharmaceuticals, Inc.
  • Amphetamine sulfate 5mg, 10mg; tablets.
  • Attention deficit hyperactivity disorder (ADHD). Narcolepsy. Short-term adjunct in managing exogenous obesity.
ZERBAXA

ZERBAXA

  • 7/12/2015
  • Merck Co., Inc.
  • 1.5g (ceftolozane 1g and tazobactam 0.5g); per vial; pwd for IV infusion after reconstitution; preservative-free; contains sodium chloride 487mg/vial.
  • Susceptible complicated intra-abdominal infections in combination with metronidazole and complicated urinary tract infections, including pyelonephritis.

UNITUXIN

  • 7/7/2015
  • United Therapeutics Corp.
  • Dinutuximab 3.5mg/mL; solution for IV infusion after dilution; preservative-free.
  • In combination with granulocyte-macrophage colony-stimulating factor, interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of children with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.
COSENTYX

COSENTYX

  • 6/28/2015
  • Novartis Pharmaceuticals Corp
  • Secukinumab 150mg/mL; soln for SC inj; and lyophilized pwd for SC inj after reconstitution; preservative-free.
  • Moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

PROAIR RESPICLICK

  • 6/21/2015
  • Teva Pharmaceuticals
  • Albuterol sulfate 90mcg/inh; dry pwd for oral inhalation with a dose counter.
  • Treatment or prevention of bronchospasm in patients ≥12 years of age with reversible obstructive airway disease. Prevention of exercise-induced bronchospasm in patients ≥12 years of age.
FARYDAK

FARYDAK

  • 6/14/2015
  • Novartis Pharmaceuticals Corp
  • Panobinostat 10mg, 15mg, 20mg; capsules.
  • Multiple myeloma, in patients who have received at least two prior regimens (including bortezomib and an immunomodulatory agent), in combination with bortezomib and dexamethasone.
EVOTAZ

EVOTAZ

  • 6/7/2015
  • BristolMyers Squibb
  • Atazanavir 300mg, cobicistat 150mg; tablets.
  • HIV-1 infection in combination with other antiretroviral agents. Limitations of use: guide use in treatment-experienced patients by number of baseline primary protease inhibitor resistance substitutions.
PREZCOBIX

PREZCOBIX

  • 5/29/2015
  • Janssen Pharmaceuticals, Inc.
  • Darunavir 800mg, cobicistat 150mg; tabs.
  • In combination with other antiretroviral agents for treatment of HIV-1 infection in adults with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M T74P, L76V, I84V, L89V).

CRESEMBA

  • 5/24/2015
  • Astellas Pharma US, Inc.
  • Isavuconazonium sulfate 186mg capsules; and 372mg/vial lyophilized powder for IV injection after reconstitution; preservative-free.
  • Invasive aspergillosis. Invasive mucormycosis.
IBRANCE

IBRANCE

  • 5/17/2015
  • Pfizer Inc.
  • Palbociclib 75mg, 100mg, 125mg; capsules.
  • In combination with letrozole, for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for metastatic disease.
SAXENDA

SAXENDA

  • 5/10/2015
  • Novo Nordisk
  • Liraglutide [rDNA origin] 6mg/mL; soln for SC inj.
  • Adjunct to reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of ≥30kg/m2 (obese), or ≥27kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, T2DM, dyslipidemia). Limitations of use: not indicated for type 2 diabetes. Do not use with Victoza, other GLP-1 receptor agonists, or insulin. Effects on cardiovascular morbidity and mortality have not been established. Safety and efficacy with concomitant other weight loss products has not been established. Not studied in patients with history of pancreatitis.
OPDIVO

OPDIVO

  • 5/3/2015
  • BristolMyers Squibb
  • Nivolumab 10mg/mL; per vial; soln for IV infusion after dilution; preservative-free; contains mannitol.
  • Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.
MOVANTIK

MOVANTIK

  • 4/26/2015
  • AstraZeneca Pharmaceuticals
  • Naloxegol 12.5mg, 25mg; tablets.
  • Opioid-induced constipation in adults with chronic non-cancer pain.
GLYXAMBI

GLYXAMBI

  • 4/19/2015
  • Boehringer Ingelheim and Lilly
  • Empagliflozin, linagliptin; 10mg/5mg, 25mg/5mg; tablets.
  • Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate. Limitations of use: not for treating type 1 diabetes or diabetic ketoacidosis. Not studied in patients with a history of pancreatitis.
LENVIMA

LENVIMA

  • 4/12/2015
  • Eisai Pharmaceuticals
  • Lenvatinib 4mg, 10mg; capsules.
  • Treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.

SAVAYSA

  • 4/5/2015
  • Daiichi Sankyo
  • Edoxaban 15mg, 30mg, 60mg; tablets.
  • To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5–10 days of initial therapy with parenteral anticoagulant. Limitations of use: not for use in NVAF patients with CrCl >95mL/min.
BELSOMRA

BELSOMRA

  • 3/29/2015
  • Merck Co., Inc.
  • Suvorexant 5mg, 10mg, 15mg, 20mg; tablets.
  • Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
RAPIVAB

RAPIVAB

  • 3/22/2015
  • BioCryst Pharmaceuticals, Inc.
  • Peramivir 10mg/mL; per vial; solution for IV injection after dilution; preservative-free.
  • Treatment of acute uncomplicated influenza in patients who have been symptomatic for ≤2 days. Limitations of use: Efficacy based on predominantly influenza A virus infections; limited number of influenza B virus subjects enrolled. Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. Efficacy not established in serious influenza requiring hospitalization.
BLINCYTO

BLINCYTO

  • 3/15/2015
  • Amgen, Inc.
  • Blinatumomab 35mcg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
  • Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
VIEKIRA PAK

VIEKIRA PAK

  • 3/8/2015
  • AbbVie
  • Ombitasvir/paritaprevir/ritonavir; 12.5mg/75mg/50mg; with dasabuvir 250mg; tablets.
  • Chronic hepatitis C virus (HCV) genotype 1 infection, with or without ribavirin, including those with compensated cirrhosis. Limitations of use: not for use in patients with decompensated liver disease.
XIGDUO XR

XIGDUO XR

  • 3/1/2015
  • AstraZeneca Pharmaceuticals
  • Dapagliflozin, metformin HCl ext-rel; 5mg/500mg, 5mg/1000mg, 10mg/500mg, 10mg/1000mg; tablets.
  • Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ­dapagliflozin and metformin is appropriate. Limitations of use: not for treating type 1 diabetes or diabetic ketoacidosis.
AKYNZEO

AKYNZEO

  • 2/22/2015
  • Eisai Pharmaceuticals
  • Netupitant, palonosetron (as HCl) 300mg/0.5mg; hard gelatin capsules.
  • Prevention of acute and delayed nausea and vomiting due to initial and repeat courses of chemotherapy, including highly emetogenic chemotherapy.
LYNPARZA

LYNPARZA

  • 2/15/2015
  • AstraZeneca Pharmaceuticals
  • Olaparib 50mg; capsules.
  • Monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with ≥3 prior lines of chemotherapy.
HARVONI

HARVONI

  • 2/8/2015
  • Gilead Sciences, Inc.
  • Ledipasvir, sofosbuvir 90mg/400mg; tablets.
  • Chronic hepatitis C (CHC) genotype 1 infection.
HYSINGLA ER

HYSINGLA ER

  • 2/1/2015
  • Purdue Pharma L.P.
  • Hydrocodone bitartrate 20mg, 30mg, 40mg, 60mg, 80mg, 100mg, 120mg; extended release tablets.
  • Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of use: reserve for use in patients for whom alternative treatment options (eg, non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or inadequate to manage pain. Not indicated as an as-needed (prn) analgesic.
DUOPA

DUOPA

  • 1/25/2015
  • AbbVie
  • Carbidopa 4.63mg (as 5mg of monohydrate), levodopa 20mg; per mL; enteral susp; use with CADD-Legacy 1400 pump.
  • Treatment of motor fluctuations in advanced Parkinson’s disease.
OFEV

OFEV

ESBRIET

ESBRIET

  • 1/11/2015
  • InterMune
  • Pirfenidone 267mg; hard gelatin capsules.
  • Treatment of idiopathic pulmonary fibrosis (IPF).
KEYTRUDA

KEYTRUDA

  • 12/14/2014
  • Merck Co., Inc.
  • Pembrolizumab 50mg; per vial; lyophilized powder for IV infusion after reconstitution; preservative-free.
  • Treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
CONTRAVE

CONTRAVE

  • 12/7/2014
  • Takeda Pharmaceuticals North America, Inc.
  • Naltrexone HCl, bupropion HCl 8mg/90mg; extended-release tablets.
  • Adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of ≥30kg/m2 or ≥27kg/m2 in the presence of at least one weight-related comorbidity (eg, hypertension, type 2 diabetes, or dyslipidemia). Limitations of use: effect on cardiovascular morbidity and mortality has not been established. Safety and efficacy in combination with other weight loss products, including Rx or OTC drugs, and herbal preps, have not been established.
TRIUMEQ

TRIUMEQ

  • 11/30/2014
  • ViiV Healthcare
  • Abacavir 600mg, dolutegravir 50mg, lamivudine 300mg; tablets.
  • HIV-1 infection. Limitations of use: not recommended alone in patients with current or history of resistance to any of the components; or alone in resistance-associated integrase substitutions or INSTI resistance due to insufficient dolutegravir dose in Triumeq in these subpopulations.
TRULICITY

TRULICITY

  • 11/23/2014
  • Lilly, Eli and Company
  • Dulaglutide 0.75mg/0.5mL, 1.5mg/0.5mL; solution for SC injection; pen or prefilled syringe.
  • Adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes. Limitations of use: not recommended as first-line treatment for patients inadequately controlled on diet and exercise. Not studied in combination with basal insulin or with history of pancreatitis. Not for treating type 1 diabetes or diabetic ketoacidosis. Not a substitute for insulin. Not recommended in patients with pre-existing severe GI disease.
ORBACTIV

ORBACTIV

  • 11/14/2014
  • The Medicines Company
  • Oritavancin 400mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains mannitol; preservative-free.
  • Acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible Gram (+) microorganisms: Staphylococcus aureus (including MRSA and MSSA), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus) and Enterococcus faecalis (vancomycin-susceptible isolates only).
ZYDELIG

ZYDELIG

  • 11/9/2014
  • Gilead Sciences, Inc.
  • Idelalisib 100mg, 150mg; tablets.
  • Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate due to other co-morbidities. Relapsed follicular B-cell non-Hodgkin lymphoma (FL) in patients who have received at least 2 prior systemic therapies. Relapsed small lymphocytic lymphoma (SLL) in patients who have received at least 2 prior systemic therapies.
CERDELGA

CERDELGA

  • 11/2/2014
  • Genzyme Corporation
  • Eliglustat 84mg; hard-gelatin caps.
  • Long-term treatment of adults with Gaucher disease type 1 who are CYP2D6 extensive, intermediate, or poor metabolizers as detected by an FDA-cleared test. Limitations of use: CYP2D6 ultra-rapid metabolizers may not achieve adequate concentrations for a therapeutic effect. No dosage recommendation for CYP2D6 indeterminate metabolizers.
CYRAMZA

CYRAMZA

  • 10/26/2014
  • Lilly, Eli and Company
  • Ramucirumab 10mg/mL; per vial; solution for IV infusion after dilution; preservative-free.
  • Treatment of patients with advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
STRIVERDI RESPIMAT

STRIVERDI RESPIMAT

  • 10/19/2014
  • Boehringer Ingelheim Pharmaceuticals
  • Olodaterol 2.5mcg; per actuation; inhalation spray; contains benzalkonium chloride.
  • Long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Limitations of use: not for treating asthma or acute deteriorations of COPD.

NORTHERA

  • 10/12/2014
  • Lundbeck Inc.
  • Droxidopa 100mg, 200mg, 300mg+; capsules; (+) contains tartrazine.
  • Orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in adults with symptomatic neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy.
KERYDIN

KERYDIN

  • 10/5/2014
  • Sandoz
  • Tavaborole 5%; topical soln; contains alcohol.
  • Treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
JARDIANCE

JARDIANCE

  • 9/28/2014
  • Boehringer Ingelheim and Lilly
  • Empagliflozin 10mg, 25mg; tablets.
  • Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of use: not for treating type 1 diabetes or diabetic ketoacidosis.
INVOKAMET

INVOKAMET

  • 9/21/2014
  • Janssen Pharmaceuticals, Inc.
  • Canagliflozin, metformin HCl 50mg/500mg, 50mg/1000mg, 150mg/500mg, 150mg/1000mg; tablets.
  • Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) who are not adequately controlled on a regimen containing metformin or canagliflozin or who are already being treated with both canagliflozin and metformin. Limitations of use: not for treating type 1 diabetes or diabetic ketoacidosis.

JUBLIA

  • 9/14/2014
  • Valeant Pharmaceuticals, Inc
  • Efinaconazole 10%; topical soln; contains alcohol.
  • Treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
DALVANCE

DALVANCE

  • 9/7/2014
  • Durata Therapeutics
  • Dalbavancin 500mg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
  • Acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible Gram (+) organisms: Staphylococcus aureus (including MRSA and MSSA), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus).

TANZEUM

  • 8/31/2014
  • GlaxoSmithKline
  • Albiglutide [recombinant fusion protein] 30mg, 50mg; per Pen; lyophilized pwd for SC inj after reconstitution; preservative-free.
  • Adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes. Limitations of use: not recommended as first-line treatment for patients inadequately controlled on diet and exercise. Not studied in combination with prandial insulin or with history of pancreatitis. Not for treating type 1 diabetes or diabetic ketoacidosis. Not a substitute for insulin. Not recommended in patients with pre-existing severe GI disease.
SIVEXTRO

SIVEXTRO

  • 8/24/2014
  • Cubist Pharmaceuticals, Inc.
  • Tedizolid phosphate 200mg; tablets; and lyophilized pwd for IV infusion after reconstitution; preservative-free.
  • Acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible Gram (+) organisms: Staphylococcus aureus (including MRSA and MSSA), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), and Enterococcus faecalis.

BELEODAQ

  • 8/17/2014
  • Spectrum Pharmaceuticals, Inc.
  • Belinostat 500mg; per vial; lyophilized pwd for IV inj after reconstitution and dilution.
  • Relapsed or refractory peripheral T-cell lymphoma (PTCL).
QUDEXY XR

QUDEXY XR

  • 8/10/2014
  • UpsherSmith Laboratories, Inc.
  • Topiramate 25mg, 50mg, 100mg, 150mg, 200mg; ext-rel caps.
  • Initial monotherapy and adjunct in partial onset or primary generalized tonic-clonic seizures. Adjunct in Lennox-Gastaut Syndrome.
ZONTIVITY

ZONTIVITY

  • 8/3/2014
  • Merck Co., Inc.
  • Vorapaxar 2.08mg (equivalent to 2.5mg of vorapaxar sulfate); tablets.
  • To reduce thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD).
ENTYVIO

ENTYVIO

  • 7/27/2014
  • Takeda Pharmaceuticals North America, Inc.
  • Vedolizumab 300mg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
  • Moderately-to-severely active ulcerative colitis: to induce and maintain clinical response and remission, to improve endoscopic mucosa appearance, and to achieve corticosteroid-free remission in adults who have had an inadequate or lost response with, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or dependent on corticosteroids. Moderately-to-severely active Crohn’s disease: to achieve clinical response and remission, and corticosteroid-free remission in adults who have had inadequate response with, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or dependent on corticosteroids.
EVZIO

EVZIO

  • 7/20/2014
  • kaleo, Inc.
  • Naloxone HCl 0.4mg/0.4mL; soln in a prefilled auto-injector for IM or SC inj; latex-free.
  • Emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or CNS depression.

ORENITRAM

  • 7/13/2014
  • United Therapeutics Corp.
  • Treprostinil 0.125mg, 0.25mg, 1mg, 2.5mg; ext-rel osmotic tabs.
  • Pulmonary arterial hypertension (PAH) (WHO Group 1) in patients with WHO functional Class II–III symptoms, to improve exercise capacity.

ZYKADIA

  • 7/6/2014
  • Novartis Pharmaceuticals Corp
  • Ceritinib 150mg; hard gel caps.
  • Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Not established for improvement in survival or disease-related symptoms.
PURIXAN

PURIXAN

  • 6/29/2014
  • Rare Disease Therapeutics, Inc.
  • Mercaptopurine (6-MP) 20mg/mL; oral suspension; contains fruit extract, aspartame.
  • Maintenance therapy of acute lymphoblastic leukemia (ALL) as part of a combination regimen.
SYLVANT

SYLVANT

  • 6/22/2014
  • Janssen Biotech, Inc.
  • Siltuximab 100mg, 400mg; lyophilized pwd for IV infusion after reconstitution; preservative-free.
  • Multicentric Castleman’s disease (MCD) in adults who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Limitation of use: not studied in patients with MCD who are HIV positive or HHV-8 positive.

ALPROLIX

  • 6/15/2014
  • Biogen Idec, Inc.
  • Coagulation Factor IX (recombinant), Fc Fusion Protein 500 IU, 1000 IU, 2000 IU, 3000 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
  • Prevention and control of bleeding in hemophilia B. Perioperative management in hemophilia B. Routine prophylaxis to prevent or reduce the frequency of bleeding in hemophilia B.
RAGWITEK

RAGWITEK

  • 6/8/2014
  • Merck Co., Inc.
  • Short ragweed pollen allergen extract (Ambrosia artemisiifolia) 12 Amb a 1-Unit; sublingual tablets.
  • Short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by (+) skin test or in vitro testing for pollen-specific IgE antibodies. Not for immediate relief of allergic symptoms.
HETLIOZ

HETLIOZ

  • 5/30/2014
  • Vanda Pharmaceuticals, Inc.
  • Tasimelteon 20mg; hard gelatin capsules.
  • Treatment of non-24-hour sleep-wake disorder (Non-24).
GRASTEK

GRASTEK

  • 5/25/2014
  • Merck Co., Inc.
  • Timothy grass pollen allergen extract 2800 bioequivalent allergy units (BAUs); sublingual tablets.
  • Grass pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by (+) skin test or in vitro testing for pollen-specific IgE antibodies. Not for immediate relief of allergic symptoms.
ORALAIR

ORALAIR

  • 5/18/2014
  • GREER Laboratories, Inc.
  • Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass mixed pollens allergen extract 100 IR (index of reactivity), 300 IR; sublingual tablets.
  • Grass pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by a (+) skin test or in vitro testing for pollen-specific IgE antibodies. Not for immediate relief of allergic symptoms.

XARTEMIS XR

  • 5/11/2014
  • Mallinckrodt, Inc.
  • Oxycodone HCl, acetaminophen 7.5mg/325mg; bilayer ext-rel tabs.
  • Acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate. Limitations of use: reserve for use in patients for whom alternative treatment options (eg, non-opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate.

MYALEPT

  • 5/4/2014
  • BristolMyers Squibb and AstraZeneca
  • Metreleptin 11.3mg; per vial; lyophilized pwd for SC inj after reconstitution (with BWFI or WFI).
  • Adjunct to diet as replacement therapy to treat leptin deficiency complications in patients with congenital or acquired generalized ­lipodystrophy. Limitations of Use: Safety and efficacy for treating partial lipodystrophy complications, or liver disease, including nonalcoholic steatohepatitis (NASH) have not been established. Not for use in HIV-related lipodystrophy or metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of congenital or acquired generalized lipodystrophy.
APTIOM

APTIOM

  • 4/27/2014
  • Sunovion
  • Eslicarbazepine acetate 200mg+, 400mg, 600mg+, 800mg+; (+) scored tabs.
  • Adjunctive treatment of partial-onset seizures.
OTEZLA

OTEZLA

  • 4/20/2014
  • Celgene Corp
  • Apremilast 10mg, 20mg, 30mg; tablets.
  • Treatment of adults with active psoriatic arthritis.
ANORO ELLIPTA

ANORO ELLIPTA

  • 4/13/2014
  • GlaxoSmithKline
  • Umeclidinium 62.5mcg, vilanterol 25mcg; per ­inhalation; dry powder for oral inhalation.
  • Long-term maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and/or emphysema. Limitations of use: not indicated for relief of acute bronchospasm or for treatment of asthma.
TRETTEN

TRETTEN

  • 4/6/2014
  • Novo Nordisk
  • Coagulation Factor XIII A-Subunit (recombinant) 2000–3125 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
  • Routine prophylaxis of bleeding in patients with congenital factor XIII (FXIII) A-subunit deficiency. Limitations of use: not for use in patients with congenital factor XIII B-subunit deficiency.
VIMIZIM

VIMIZIM

  • 3/30/2014
  • BioMarin Pharmaceuticals
  • Elosulfase alfa 1mg/mL; soln for IV infusion; preservative-free.
  • Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).
OTREXUP

OTREXUP

  • 3/23/2014
  • Antares Pharma
  • Methotrexate (MTX) 10mg/0.4mL, 15mg/0.4mL, 20mg/0.4mL, 25mg/0.4mL; soln for SC inj; preservative-free.
  • Management of adults with severe, active rheumatoid arthritis (RA) or children with active polyarticular juvenile idiopathic arthritis (pJIA), who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose NSAIDs. Symptomatic control of severe, recalcitrant, disabling psoriasis in adults with inadequate response to other forms of therapy, but only with an established diagnosis as by biopsy and/or dermatologic consultation. Limitation of use: not for treating neoplastic diseases.

ZOHYDRO ER

  • 3/16/2014
  • Zogenix, Inc.
  • Hydrocodone bitartrate 10mg, 15mg, 20mg, 30mg, 40mg, 50mg; extended-release caps.
  • Management of pain severe enough to require daily, around-the-clock, long-term opioid tx and for which alternative tx (eg, non-opioid analgesics or immediate-release opioids) are inadequate. Limitations of use: reserve for use in patients for whom alternative tx options are ineffective, not tolerated, or inadequate to manage pain. Not indicated as an as-needed (prn) analgesic.
DUAVEE

DUAVEE

  • 3/9/2014
  • Pfizer Inc.
  • Conjugated estrogens 0.45mg, bazedoxifene 20mg; tabs.
  • Treatment of moderate-to-severe vasomotor symptoms associated with menopause. Prevention of postmenopausal osteoporosis. Limitation of use: use for shortest duration consistent with treatment goals and risks.
IMBRUVICA

IMBRUVICA

  • 3/2/2014
  • Pharmacyclics and Janssen Biotech
  • Ibrutinib 140mg; caps.
  • Treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Both indications are based on overall response rate. An improvement in survival or disease-related symptoms has not been established.
FARXIGA

FARXIGA

  • 2/23/2014
  • BristolMyers Squibb and AstraZeneca
  • Dapagliflozin 5mg, 10mg; tablets.
  • Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitation of use: not for treating type 1 diabetes mellitus or diabetic ketoacidosis.
GAZYVA

GAZYVA

  • 2/16/2014
  • Genentech, Inc.
  • Obinutuzumab 25mg/mL; soln for IV infusion after dilution; preservative-free.
  • Treatment of patients with previously untreated chronic lymphocytic leukemia (CLL), in combination with chlorambucil.
SOVALDI

SOVALDI

  • 2/9/2014
  • Gilead Sciences, Inc.
  • Sofosbuvir 400mg; tabs.
  • As a component of a combination antiviral treatment regimen for chronic hepatitis C (CHC) genotype 1, 2, 3, or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplant), and those with HCV/HIV-1 co-infection. Not for use as monotherapy.
OLYSIO

OLYSIO

  • 2/2/2014
  • Janssen Therapeutics
  • Simeprevir 150mg; caps.
  • Chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in patients with compensated liver disease, including cirrhosis. Not for use as monotherapy. Screen for presence of virus with NS3Q80K polymorphism at baseline; consider alternative therapy if Q80K polymorphism is present.
FYCOMPA

FYCOMPA

  • 1/26/2014
  • Eisai Pharmaceuticals
  • Perampanel 2mg, 4mg, 6mg, 8mg, 10mg, 12mg; tabs.
  • Adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients ≥12 years of age.
BRINTELLIX

BRINTELLIX

  • 1/19/2014
  • Takeda and Lundbeck
  • Vortioxetine 5mg, 10mg, 20mg; tabs.
  • Treatment of adults with major depressive disorder (MDD).
SURFAXIN

SURFAXIN

  • 1/12/2014
  • Discovery Laboratories, Inc.
  • Lucinactant 8.5mL/vial; contains phospholipids 30mg (dipalmitoylphosphatidylcholine 22.5mg, palmitoyloleoyl-phosphatidylglycerol 7.5mg, sodium salt), palmitic acid 4.05mg, sinapultide 0.862mg; per mL; susp for intratracheal administration; preservative-free.
  • For the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS.
ADEMPAS

ADEMPAS

  • 12/15/2013
  • Bayer Healthcare Pharmaceuticals Inc.
  • Riociguat 0.5mg, 1mg, 1.5mg, 2mg, 2.5mg; tabs.
  • Treatment of persistent/recurrent chronic thromboembolic ­pulmonary hypertension (CTEPH), (Who Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class. Pulmonary arterial hypertension (PAH), (Who Group 1) to improve exercise capacity, WHO functional class, and to delay clinical worsening.
BRISDELLE

BRISDELLE

  • 12/8/2013
  • Noven Therapeutics
  • Paroxetine (as mesylate) 7.5mg; capsules.
  • Moderate to severe vasomotor symptoms associated with menopause. Limitation of use: not indicated for treatment of any psychiatric condition.
OPSUMIT

OPSUMIT

  • 12/1/2013
  • Actelion Pharmaceuticals
  • Macitentan 10mg; tabs.
  • Treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to delay disease progression. In clinical studies, treatment delayed disease progression (death, initiation of IV or SC prostanoids, or clinical worsening of PAH [decreased 6MWD, worsened PAH symptoms and need for additional PAH treatment]) and reduced hospitalization for PAH.
VALCHLOR

VALCHLOR

  • 11/24/2013
  • Actelion Pharmaceuticals
  • Mechlorethamine 0.016%; topical gel; contains propylene glycol, isopropyl alcohol.
  • Treatment of Stage IA and IB mycosis fungoides-type ­cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy.
GRANIX

GRANIX

  • 11/17/2013
  • Teva Pharmaceuticals
  • Tbo-filgrastim 300mcg/0.5mL, 480mcg/0.8mL; soln for SC inj; preservative-free.
  • To reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
FETZIMA

FETZIMA

  • 11/10/2013
  • Forest Laboratories
  • Levomilnacipran 20mg, 40mg, 80mg, 120mg; ext-rel caps.
  • Treatment of major depressive disorder (MDD) in adults. Limitations of use: not approved for the management of fibromyalgia. The efficacy and safety for the management of fibromyalgia have not been established.
BREO ELLIPTA

BREO ELLIPTA

  • 11/3/2013
  • GlaxoSmithKline
  • Fluticasone furoate 100mcg, vilanterol 25mcg; per inhalation; dry powder for oral inhalation.
  • Long term maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and/or emphysema. To reduce exacerbations of COPD in patients with a history of exacerbations.
    Limitations of use: not indicated for relief of acute bronchospasm or for treatment of asthma.
ZUBSOLV

ZUBSOLV

  • 10/27/2013
  • Orexo U.S.
  • Buprenorphine (as HCl), naloxone (as HCl dihydrate); 1.4mg/0.36mg, 5.7mg/1.4mg; sublingual tabs; menthol-flavor.
  • Maintenance treatment of opioid dependence, as part of a complete treatment plan to include counseling and psychosocial support.
GILOTRIF

GILOTRIF

  • 10/20/2013
  • Boehringer Ingelheim Pharmaceuticals
  • Afatinib 20mg, 30mg, 40mg; tabs.
  • First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions as detected by an FDA-approved test. Limitations of use: safety and efficacy of Gilotrif have not been established in patients whose tumors have other EGFR mutations.
KHEDEZLA

KHEDEZLA

MIRVASO

MIRVASO

  • 10/6/2013
  • Galderma Laboratories, Inc.
  • Brimonidine tartrate 0.33%; topical gel; contains propylene glycol.
  • Treatment of persistent (nontransient) facial erythema of rosacea.
ADASUVE

ADASUVE

  • 9/29/2013
  • Teva Pharmaceuticals
  • Loxapine 10mg; powder for oral inhalation.
  • Acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Limitations of use: must be administered only in an enrolled healthcare facility.
TAFINLAR

TAFINLAR

  • 9/20/2013
  • GlaxoSmithKline
  • Dabrafenib 50mg, 75mg; caps.
  • Treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation, as detected by an FDA-approved test. Limitation of use: not indicated for the treatment of patients with wild-type BRAF melanoma.
MEKINIST

MEKINIST

  • 9/17/2013
  • GlaxoSmithKline
  • Trametinib 0.5mg, 1mg, 2mg; tabs.
  • Treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test. Limitation of use: not indicated for the treatment of patients who have received prior BRAF-inhibitor therapy.
XOFIGO

XOFIGO

  • 9/5/2013
  • Bayer Healthcare Pharmaceuticals Inc.
  • Radium Ra 223 dichloride 1000 kBq/mL (27 microcurie/mL) with a total radioactivity of 6000 kBq/vial (162 microcurie/vial) at the reference date; IV injection.
  • Treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
TIVICAY

TIVICAY

  • 9/1/2013
  • ViiV Healthcare
  • Dolutegravir 50mg; tablets.
  • In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children ≥12 years and ≥40kg.
FULYZAQ

FULYZAQ

  • 8/25/2013
  • Salix Pharmaceuticals, Inc.
  • Crofelemer 125mg; delayed-release tablets; enteric-coated.
  • Symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.
OSENI

OSENI

  • 8/18/2013
  • Takeda Pharmaceuticals North America, Inc.
  • Alogliptin, pioglitazone; 12.5mg/15mg, 12.5mg/30mg, 12.5mg/45mg, 25mg/15mg, 25mg/30mg, 25mg/45mg; tabs.
  • As adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) when treatment with both alogliptin and pioglitazone is appropriate.
    Limitations of use: not for treatment of type 1 diabetes or diabetic ketoacidosis.
KAZANO

KAZANO

  • 8/11/2013
  • Takeda Pharmaceuticals North America, Inc.
  • Alogliptin, metformin (as HCl); 12.5mg/500mg, 12.5mg/1000mg; tabs.
  • Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) when treatment with both alogliptin and metformin is appropriate.
    Limitations of use: not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
NESINA

NESINA

  • 8/4/2013
  • Takeda Pharmaceuticals North America, Inc.
  • Alogliptin 6.25mg, 12.5mg, 25mg; tabs.
  • As adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM).
    Limitations of use: not for treatment of type 1 diabetes or diabetic ketoacidosis.
GATTEX

GATTEX

  • 7/28/2013
  • NPS Pharmaceuticals
  • Teduglutide 5mg; per vial; lyophilized pwd for SC inj after reconstitution.
  • Treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support.

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