New Drug Product Slideshows

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.

Northera

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, dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy.

Kerydin

Treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Jardiance

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

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.

New Products

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.