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 Pharmaceuticals
  • 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 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).

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