New Drug Product Slideshows

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.

Jublia

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

Dalvance

Acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram (+) organisms.

Tanzeum

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

Sivextro

Acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible Gram (+) organisms

Beleodaq

Relapsed or refractory peripheral T-cell lymphoma (PTCL)

Qudexy XR

Initial monotherapy and adjunct in partial onset or primary generalized tonic-clonic seizures.

Zontivity

To reduce thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD).

New Products

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.