New Products

VRAYLAR

  • 4/25/2016
  • Actavis
  • Cariprazine 1.5mg, 3mg, 4.5mg, 6mg; capsules.
  • Treatment of schizophrenia. Acute treatment of manic or mixed episodes associated with bipolar I disorder.

NINLARO

  • 4/17/2016
  • Takeda Pharmaceuticals North America, Inc.
  • Ixazomib 2.3mg, 3mg, 4mg; gel caps.
  • In combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least 1 prior therapy.

PRAXBIND

  • 4/10/2016
  • Boehringer Ingelheim Pharmaceuticals
  • Idarucizumab 2.5g/50mL; soln for IV infusion; preservative-free; contains sorbitol.
  • Reversal of the anticoagulant effects of dabigatran in patients requiring emergency surgery/urgent procedure or experiencing life-threatening or uncontrolled bleeding.
TAGRISSO

TAGRISSO

  • 4/3/2016
  • AstraZeneca Pharmaceuticals
  • Osimertinib 40mg, 80mg; tablets.
  • Treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor therapy.

SEEBRI NEOHALER

  • 3/27/2016
  • Novartis Pharmaceuticals Corp
  • Glycopyrrolate 15.6mcg; per capsule; dry powder for oral inhalation for use with Neohaler device; contains lactose.
  • Long-term maintenance treatment of airflow obstruction due to chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
ONIVYDE

ONIVYDE

  • 3/20/2016
  • Merrimack Pharmaceuticals, Inc.
  • Irinotecan 43mg/10mL; liposomal dispersion for IV use.
  • In combination with fluorouracil and leucovorin, for treatment of metastatic adenocarcincoma of the pancreas after disease progression following gemcitabine-based therapy. Limitations of use: as a single agent, not for the treatment of metastatic adenocarcinoma of the pancreas.
ODEFSEY

ODEFSEY

  • 3/13/2016
  • Gilead Sciences, Inc.
  • Emtricitabine 200mg, rilpivirine 25mg, tenofovir alafenamide (TAF) 25mg; tabs.
  • As a complete regimen for HIV-1 infection in patients who are antiretroviral treatment-naïve with HIV-1 RNA ≤100,000 copies/mL or to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA <50 copies/mL) for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to any components of Odefsey.

ZEPATIER

  • 3/6/2016
  • Merck Co., Inc.
  • Elbasvir, grazoprevir 50mg/100mg; tablets.
  • Chronic HCV genotypes 1 or 4 infection with or without ribavirin (RBV).

BASAGLAR

  • 2/28/2016
  • Boehringer Ingelheim and Lilly
  • Insulin glargine (recombinant) 100 Units/mL; for SC inj; contains m-cresol.
  • Type 1 diabetes (in adults and children) and type 2 diabetes (in adults). Limitations of use: not for treating diabetic ketoacidosis.

UPTRAVI

  • 2/21/2016
  • Actelion Pharmaceuticals
  • Selexipag 200mcg, 400mcg, 600mcg, 800mcg, 1000mcg, 1200mcg, 1400mcg, 1600mcg; tablets.
  • Pulmonary arterial hypertension (PAH) (WHO Group 1) in patients with WHO functional Class II–III symptoms, to delay disease progression and reduce the risk of hospitalization for PAH.

PORTRAZZA

  • 2/14/2016
  • Lilly, Eli and Company
  • Necitumumab 800mg/50mL; solution for IV infusion after dilution; preservative-free.
  • In combination with gemcitabine and cisplatin, for first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC). Limitations of use: not for treatment of non-squamous NSCLC.
UTIBRON NEOHALER

UTIBRON NEOHALER

  • 2/7/2016
  • Novartis Pharmaceuticals Corp
  • Indacaterol 27.5mcg, glycopyrrolate 15.6mcg; per capsule; dry powder for oral inhalation for use with Neohaler device; contains lactose.
  • Long-term maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and/or emphysema. Limitations of use: not for the relief of acute bronchospasm or for the treatment of asthma.
EMPLICITI

EMPLICITI

  • 1/31/2016
  • BristolMyers Squibb
  • Elotuzumab 300mg, 400mg; per vial; lyophilized powder for IV infusion after reconstitution; preservative-free.
  • In combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received 1–3 prior therapies.
BELBUCA

BELBUCA

  • 1/24/2016
  • Endo Pharmaceuticals
  • Buprenorphine 75mcg, 150mcg, 300mcg, 450mcg, 600mcg, 750mcg, 900mcg; buccal films; peppermint flavor.
  • 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 are ineffective, not tolerated, or inadequate to provide sufficient management of pain. Not indicated as an as-needed (prn) analgesic.
DARZALEX

DARZALEX

  • 1/17/2016
  • Janssen Biotech, Inc.
  • Daratumumab 100mg/5mL, 400mg/20mL; per vial; soln for IV infusion after dilution; contains mannitol; preservative-free.
  • Treatment of multiple myeloma in patients who have received ≥3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
NUCALA

NUCALA

  • 1/10/2016
  • GlaxoSmithKline
  • Mepolizumab 100mg; per vial; lyophilized pwd for SC inj after reconstitution; preservative-free.
  • As add-on maintenance treatment of severe asthma in patients ≥12yrs old, and with an eosinophilic phenotype. Limitations of use: not for treating other eosinophilic conditions. Not for relief of acute bronchospasm or status asthmaticus.
GENVOYA

GENVOYA

  • 12/27/2015
  • Gilead Sciences, Inc.
  • Elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, tenofovir alafenamide (AF) 10mg; tablets.
  • As a complete regimen for the treatment of HIV-1 infection in patients who are antiretroviral treatment-naïve or to replace current antiretroviral (ARV) regimen in virologically-suppressed patients on a stable ARV regimen for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to any components of Genvoya.
COTELLIC

COTELLIC

  • 12/20/2015
  • Genentech, Inc.
  • Cobimetinib 20mg; tablets.
  • In combination with vemurafenib for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test. Limitation of use: not for treatment of wild-type BRAF melanoma.

VIBERZI

  • 12/13/2015
  • Allergan
  • Eluxadoline 75mg, 100mg; tablets.
  • Treatment of irritable bowel syndrome with diarrhea (IBS-D).

TRESIBA

  • 12/6/2015
  • Novo Nordisk
  • Insulin degludec 100 Units/mL, 200 Units/mL; soln for SC inj; contains zinc, m-cresol.
  • To improve glycemic control in adults with type 1 or type 2 diabetes mellitus. Limitations of use: not for treating diabetic ketoacidosis.

New Drug Product Slideshows

Genvoya

As a complete regimen for the treatment of HIV-1 infection in patients who are antiretroviral treatment-naïve or to replace current antiretroviral (ARV) regimen in virologically-suppressed patients on a stable ARV regimen for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to any components of Genvoya.

Viberzi

New Drug Product: TRESIBA

This slideshow reviews drug information for TRESIBA (insulin degludec). <a href="http://www.empr.com/tresiba/drugproduct/397/">Click here</a> for the complete TRESIBA new product monograph<br /> <br /> <b>For a downloadable PDF of this slideshow, <a href="http://www.empr.com/downloadmedia/45272">click here</a>.</b>

Lonsurf

Treatment of metastatic colorectal cancer in patients previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

Varubi

In combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

Strensiq

Treatment of perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).

Colcigel

Treatment and prophylaxis of acute gout flares.

Aristada

Indications: Schizophrenia.