New Drug Product Slideshows

Contrave

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).

Triumeq

HIV-1 infection.

Trulicity

Adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes.

Orbactiv

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

Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate due to other co-morbidities.

Cerdelga

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.

Cyramza

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

Long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

New Products

KEYTRUDA

KEYTRUDA

  • 12/14/2014
  • Merck Co., Inc.
  • Pembrolizumab 50mg; 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).