ANORO ELLIPTA

  • 4/13/2014
  • GlaxoSmithKline Pharmaceuticals
  • 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 Pharmaceuticals
  • 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 Pharmaceuticals
  • 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 Pharmaceuticals
  • 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.
OSPHENA

OSPHENA

  • 7/21/2013
  • Shionogi, Inc.
  • Ospemifene 60mg; tabs.
  • Treatment of moderate-to-severe dyspareunia due to menopause.
TOBI PODHALER

TOBI PODHALER

  • 7/14/2013
  • Novartis Pharmaceuticals Corp
  • Tobramycin 28mg/cap; dry pwd in caps for oral inhalation; with Podhaler device.
  • Management of cystic fibrosis patients with P. aeruginosa. Safety and efficacy have not been demonstrated in patients <6yrs, in those with FEV1 <25% or >80% predicted, or patients colonized with B. cepacia.
DICLEGIS

DICLEGIS

  • 7/7/2013
  • Duchesnay USA, Inc.
  • Doxylamine succinate 10mg, pyridoxine HCl 10mg; delayed-release tablets.
  • Treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management.
    Limitations of use: has not been studied in women with hyperemesis gravidarum.
SIRTURO

SIRTURO

  • 6/30/2013
  • Janssen Therapeutics
  • Bedaquiline 100mg; tabs.
  • As part of combination therapy in pulmonary multi-drug resistant tuberculosis (MDR-TB) only when an effective treatment regimen cannot otherwise be provided.

    Limitations of use: the safety and efficacy for treatment of latent infection, drug-sensitive, or extra-pulmonary tuberculosis (eg, CNS) has not been established.

BELVIQ

BELVIQ

  • 6/23/2013
  • Eisai Pharmaceuticals
  • Lorcaserin HCl 10mg; tabs.
  • As an 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 [HTN], dyslipidemia, type 2 diabetes mellitus [T2DM]).
    Limitations of use: safety and efficacy of coadministration with other weight loss products (eg, phentermine, OTC drugs, herbal preps) have not been established. Effect on cardiovascular morbidity and mortality has not been established.
GIAZO

GIAZO

  • 6/16/2013
  • Salix Pharmaceuticals, Inc.
  • Balsalazide disodium (prodrug of mesalamine) 1.1g; tabs; contains sodium 126mg/tab.
  • Treatment of mildly-to-moderately active ulcerative colitis in male patients.

    Limitations of use: effectiveness in treatment of female patients was not demonstrated. Safety and effectiveness of therapy beyond 8 weeks have not been established.

LIPTRUZET

LIPTRUZET

  • 6/9/2013
  • Merck Co., Inc.
  • Ezetimibe/atorvastatin; 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg; tabs.
  • To reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in primary (heterozygous familial and non-familial) or mixed hyperlipidemia. To reduce elevated total-C and LDL-C in homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable. Limitations of use: No incremental benefit on cardiovascular morbidity/mortality over and above that demonstrated for atorvastatin has been established. Not studied in Fredrickson type I, III, IV, and V dyslipidemias.
TECFIDERA

TECFIDERA

  • 6/2/2013
  • Biogen Idec, Inc.
  • Dimethyl fumarate 120mg, 240mg; delayed-release caps.
  • Treatment of patients with relapsing forms of multiple sclerosis.
POMALYST

POMALYST

  • 5/26/2013
  • Celgene Corp
  • Pomalidomide 1mg, 2mg, 3mg, 4mg; capsules.
  • Multiple myeloma, in patients who have received at least two prior therapies (including lenalidomide and bortezomib), and have shown disease progression on or within 60 days of completion of the last therapy. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
KYNAMRO

KYNAMRO

  • 5/19/2013
  • Genzyme Corporation
  • Mipomersen sodium 200mg/mL; soln for SC inj; preservative-free.
  • Adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (TC), and non-high density lipoprotein-cholesterol (non HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).
KADCYLA

KADCYLA

  • 5/12/2013
  • Genentech, Inc.
  • Ado-trastuzumab emtansine 100mg, 160mg; per vial; powder; for IV infusion after reconstitution.
  • Treatment in patients with HER2-positive (+), metastatic breast cancer (MBC) who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease or developed disease recurrence during or within 6 months of completing adjuvant therapy.
INVOKANA

INVOKANA

  • 5/5/2013
  • Janssen Pharmaceuticals, Inc.
  • Canagliflozin 100mg, 300mg; tablets.
  • Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). Limitation of use: not for treatment of type 1 diabetes or diabetic ketoacidosis.
AUVIQ

AUVIQ

  • 4/28/2013
  • Sanofi Aventis
  • Epinephrine 0.3mg, 0.15mg; pre-filled auto-injector (includes audible and visible cues for use).
  • Emergency treatment of allergic reactions (Type 1) including anaphylaxis.
VARIZIG

VARIZIG

  • 4/21/2013
  • Cangene Corporation
  • Varicella zoster immune globulin (human) 125 IU; per vial; lyophilized pwd for IM inj after reconstitution; contains <250mg of total protein (mostly human IgG), <40mcg/mL of IgA; preservative- and mercury-free.
  • Postexposure prophylaxis of varicella in high risk individuals (include immunocompromised children and adults, newborns of mothers with varicella shortly before or after delivery, premature infants, neonates and infants <1 year old, adults without evidence of immunity, pregnant women). To reduce severity of varicella.
MINIVELLE

MINIVELLE

  • 4/14/2013
  • Noven Therapeutics
  • Estradiol 0.0375mg/day, 0.05mg/day, 0.075mg/day, 0.1mg/day; transdermal patch.
  • Moderate-to-severe vasomotor symptoms due to menopause.
SIGNIFOR

SIGNIFOR

  • 4/7/2013
  • Novartis Pharmaceuticals Corp
  • Pasireotide diaspartate 0.3mg/mL, 0.6mg/mL, 0.9mg/mL; soln for SC inj.
  • Treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.
MARQIBO

MARQIBO

  • 3/31/2013
  • Talon Therapeutics, Inc.
  • Vincristine sulfate liposome injection; after preparation, each vial contains 0.16mg/mL; for IV infusion.
  • Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or has progressed following ≥2 anti-leukemia therapies.
ICLUSIG

ICLUSIG

  • 3/24/2013
  • ARIAD Pharmaceuticals, Inc.
  • Ponatinib 15mg, 45mg; tabs.
  • Chronic, accelerated, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy. Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.
SKYLA

SKYLA

RAYOS

RAYOS

  • 3/10/2013
  • Horizon Pharma
  • Prednisone 1mg, 2mg, 5mg; delayed-release tablets.
  • Corticosteroid-responsive disorders.
SYNRIBO

SYNRIBO

  • 3/3/2013
  • Teva Pharmaceuticals
  • Omacetaxine mepesuccinate 3.5mg/vial; lyophilized powder for SC injection after reconstitution; contains mannitol; ­preservative-free.
  • Treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI).
ELIQUIS

ELIQUIS

  • 2/24/2013
  • BristolMyers Squibb and Pfizer
  • Apixaban 2.5mg, 5mg; tablets.
  • To reduce risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF).
UCERIS

UCERIS

  • 2/17/2013
  • Santarus, Inc.
  • Budesonide 9mg; extended-release tabs.
  • Induction of remission in patients with active, mild-to-moderate ulcerative colitis.
OXTELLAR XR

OXTELLAR XR

  • 2/10/2013
  • Supernus Pharmaceuticals
  • Oxcarbazepine 150mg, 300mg, 600mg; extended-release tablets.
  • Adjunctive therapy in the treatment of partial seizures in adults and in children 6–17 years of age.
VASCEPA

VASCEPA

  • 2/3/2013
  • Amarin Pharma
  • Icosapent ethyl 1g; soft gelatin capsules.
  • Adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500mg/dL) hypertriglyceridemia. Limitations of use: The effect of Vascepa on the risk for pancre­atitis in patients with severe hypertriglyceridemia has not been determined. The effect of Vascepa on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
QUILLIVANT XR

QUILLIVANT XR

  • 1/27/2013
  • Pfizer Inc.
  • Methylphenidate HCl extended-release 5mg/mL; pwd for oral suspension after reconstitution.
  • Attention deficit hyperactivity disorder (ADHD).
COMETRIQ

COMETRIQ

  • 1/20/2013
  • Exelixis, Inc.
  • Cabozantinib 20mg, 80mg; caps.
  • Treatment of progressive, metastatic medullary thyroid cancer (MTC).
ULTRESA 13800

ULTRESA 13800

  • 1/13/2013
  • Aptalis Pharmaceutical Technologies
  • Lipase 13800, protease 27600, amylase 27600; del-rel caps; e-c minitabs in caps.
  • Treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions.
JUXTAPID

JUXTAPID

  • 1/6/2013
  • Aegerion Pharmaceuticals, Inc.
  • Lomitapide mesylate 5mg, 10mg, 20mg; caps.
  • As an adjunct to low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce LDL-C, total cholesterol, apo B, and non-HDL-C in patients with homozygous familial hypercholesterolemia (HoFH). Not for patients with hypercholesterolemia who do not have HoFH. Effect on cardiovascular morbidity, mortality has not been determined.
XELJANZ

XELJANZ

  • 12/23/2012
  • Pfizer Inc.
  • Tofacitinib 5mg tabs.
  • Treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX); may be used as monotherapy or in combination with MTX or other nonbiologic disease-modifying anti-rheumatic drugs (DMARDs). Do not use in combination with biologic DMARDs or potent immunosuppressants (eg, azathioprine, cyclosporine).
LINZESS

LINZESS

  • 12/16/2012
  • Forest and Ironwood
  • Linaclotide 145mcg, 290mcg; capsules.
  • Irritable bowel syndrome with constipation (IBS-C). Chronic idiopathic constipation (CIC).
TUDORZA PRESSAIR

TUDORZA PRESSAIR

  • 12/9/2012
  • Forest Laboratories
  • Aclidinium bromide 400mcg/actuation; dry powder for oral inhalation.
  • Long-term, maintenance treatment of bronchospasm associated with COPD, ­including chronic bronchitis and emphysema.
STRIBILD

STRIBILD

  • 11/30/2012
  • Gilead Sciences, Inc.
  • Elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, tenofovir disoproxil fumarate (DF) 300mg; tablets.
  • Treatment of HIV-1 infection in adults who are antiretroviral treatment-naïve.
NUVAIL

NUVAIL

  • 11/26/2012
  • Innocutis
  • Poly-ureaurethane 16%; nail solution.
  • For managing signs/symptoms of nail dystrophy (eg, nail splitting, fragility) for intact or damaged nails.
STIVARGA

STIVARGA

  • 11/18/2012
  • Bayer Healthcare Pharmaceuticals Inc.
  • Regorafenib 40mg; tablets.
  • Treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.
BOSULIF

BOSULIF

  • 11/11/2012
  • Pfizer Inc.
  • Bosutinib 100mg, 500mg; tablets.
  • Treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy.
AUBAGIO

AUBAGIO

  • 11/5/2012
  • Genzyme Corporation
  • Teriflunomide 7mg, 14mg; tablets.
  • Relapsing forms of multiple sclerosis (MS).
BINOSTO

BINOSTO

  • 10/29/2012
  • Mission Pharmacal Company
  • Alendronate (as sodium) 70mg; effervescent tabs for oral soln; strawberry-flavor; contains 650mg sodium/tab.
  • Treatment of postmenopausal osteoporosis. To increase bone mass in men with osteoporosis.
PREPOPIK

PREPOPIK

  • 10/22/2012
  • Ferring Pharmaceuticals, Inc.
  • Sodium picosulfate 10mg, mag­nesium oxide 3.5g, anhydrous citric acid 12g; per packet; powder for oral solution after reconstitution.
  • Bowel cleansing before colonoscopy.
MYRBETRIQ

MYRBETRIQ

  • 10/15/2012
  • Astellas Pharma
  • Mirabegron 25mg, 50mg; extended-release tablets.
  • Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
DYMISTA

DYMISTA

  • 10/8/2012
  • Meda Pharmaceuticals
  • Azelastine hydrochloride (HCl), fluticasone propionate 137mcg/50mcg; per 0.137mL metered nasal spray; aqueous suspension.
  • Seasonal allergic rhinitis.
QSYMIA

QSYMIA

  • 10/1/2012
  • Vivus, Inc.
  • Phentermine HCl/topiramate extended-release; 3.75mg/23mg, 7.5mg/46mg, 11.25mg/69mg, 15mg/92mg; caps.
  • As an 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 co-morbidity (eg, HTN, T2DM or dyslipidemia).
XTANDI

XTANDI

  • 9/24/2012
  • Astellas Pharma US, Inc.
  • Enzalutamide 40mg; caps.
  • Treatment of metastatic castration-resistant prostate cancer in patients who have previously received docetaxel.
ZALTRAP

ZALTRAP

  • 9/3/2012
  • Sanofi and Regeneron
  • Ziv-aflibercept 25mg/mL; soln for IV infusion after dilution; preservative-free.
  • In combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI) for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.
SORILUX

SORILUX

  • 8/13/2012
  • Stiefel Laboratories, Inc.
  • Calcipotriene (as monohydrate) 0.005%; foam.
  • Topical treatment of plaque psoriasis in patients ≥18 years of age.
KYPROLIS

KYPROLIS

  • 8/7/2012
  • Onyx Pharmaceuticals
  • Carfilzomib 60mg/vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
  • Treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy.
ZETONNA

ZETONNA

  • 8/6/2012
  • Sunovion
  • Ciclesonide 37micrograms/actuation; metered-dose nasal aerosol; contains HFA.
  • Treatment of symptoms associated with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in patients ≥12 years of age.
KYPROLIS

KYPROLIS

  • 7/30/2012
  • Onyx Pharmaceuticals
  • Carfilzomib 60mg/vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
  • Treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy.
SKLICE

SKLICE

  • 7/23/2012
  • Sanofi Pasteur, Inc.
  • Ivermectin 0.5%; lotion.
  • Topical treatment of head lice infestations in patients ≥6 months old.
VIOKACE 10440

VIOKACE 10440

  • 7/16/2012
  • Aptalis Pharmaceutical Technologies
  • Lipase 10440 units, protease 39150 units, amylase 39150 units; tabs.
  • Treatment of exocrine pancreatic insufficiency in adults due to chronic pancreatitis or pancreatectomy, in combination with a proton pump inhibitor.
PERJETA

PERJETA

  • 7/9/2012
  • Genentech, Inc.
  • Pertuzumab 420mg/14mL (30mg/mL); soln for IV infusion; preservative-free.
  • In combination with trastuzumab and docetaxel: to treat patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
PERTZYE 8000

PERTZYE 8000

  • 7/2/2012
  • Digestive Care, Inc.
  • Lipase 8000 units, protease 28750 units, amylase 30250 units; delayed-release caps.
  • Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
POTIGA

POTIGA

  • 6/25/2012
  • GlaxoSmithKline Pharmaceuticals
  • Ezogabine 50mg, 200mg, 300mg, 400mg; tablets.
  • Adjunctive treatment of partial-onset seizures in patients ≥18 years old.
ELELYSO

ELELYSO

  • 6/18/2012
  • Pfizer Inc.
  • Taliglucerase alfa (recombinant) 200 Units; per vial; lyophilized pwd; for IV infusion after reconstitution; preservative-free.
  • Long-term enzyme replacement therapy (ERT) for adults with Type 1 Gaucher disease.
OMECLAMOXPAK

OMECLAMOXPAK

  • 6/11/2012
  • Pernix Therapeutics
  • Omeprazole 20mg (2 del-rel caps containing enteric-coated granules), clarithromycin 500mg (2 tabs), amoxicillin 500mg (4 caps); per daily administration card.
  • Treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history) to eradicate H. pylori.
SUPRENZA

SUPRENZA

  • 6/4/2012
  • Akrimax Pharmaceuticals
  • Phentermine HCl 15mg, 30mg, 37.5mg; orally-disintegrating tabs (ODT); peppermint-flavor.
  • A short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30kg/m2, or ≥27kg/m2 in the presence of other risk factors (eg, hypertension, diabetes, hyperlipidemia).
OMONTYS

OMONTYS

  • 5/28/2012
  • Affymax and Takeda
  • Peginesatide 2mg, 3mg, 4mg, 5mg, 6mg per 0.5mL single-use vial (preservative-free); 1mg, 2mg, 3mg, 4mg, 5mg, 6mg per 0.5mL single-use prefilled syringe (preservative-free); 10mg/mL, 20mg/2mL multiple-use vial (w. preservatives); solution for IV or SC injection.
  • Anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
DUTOPROL

DUTOPROL

  • 5/21/2012
  • AstraZeneca Pharmaceuticals
  • Metoprolol succinate extended-release, hydrochlorothiazide; 25/12.5mg, 50/12.5mg, 100/12.5mg; tablets.
  • Hypertension.
KORLYM

KORLYM

  • 5/14/2012
  • Corcept Therapeutics
  • Mifepristone 300mg; tabs.
  • To control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and have failed surgery or are not candidates for surgery.
VORAXAZE

VORAXAZE

  • 5/7/2012
  • BTG International
  • Glucarpidase; 1,000 Units/vial; lyophilized powder for IV injection after reconstitution; preservative-free.
  • Treatment of toxic plasma metho­trexate (MTX) concentrations (>1 micromole per liter) in patients with delayed MTX clearance due to impaired renal function.
QNASL

QNASL

  • 4/30/2012
  • Teva Pharmaceuticals
  • Beclomethasone dipropionate 80mcg/actuation; non-aqueous nasal spray soln.
  • Seasonal and perennial allergic rhinitis.
EXPAREL

EXPAREL

  • 4/23/2012
  • Pacira Pharmaceuticals
  • Bupivacaine 13.3mg/mL; liposome injectable suspension; preservative-free.
  • For administration into the surgical site to produce postsurgical analgesia.
ARCAPTA NEOHALER

ARCAPTA NEOHALER

  • 4/16/2012
  • Novartis Pharmaceuticals Corp
  • Indacaterol 75mcg; inhalation pwd hard capsules for use with Neohaler device.
  • Long-term maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and/or emphysema.
ZIOPTAN

ZIOPTAN

  • 4/9/2012
  • Merck Co., Inc.
  • Tafluprost 0.0015%; oph soln; preservative-free.
  • For reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
INTERMEZZO

INTERMEZZO

  • 4/2/2012
  • Purdue Pharma L.P.
  • Zolpidem tartrate 1.75mg, 3.5mg; sublingual tablets.
  • As needed use for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Not indicated for treatment of middle-of-the-night insomnia when the patient has <4 hours of bedtime remaining before the planned time of waking.

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