New Drug Product Slideshows

Evzio

Emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or CNS depression.

Orenitram

Pulmonary arterial hypertension (PAH) (WHO Group 1) in patients with WHO functional Class II–III symptoms, to improve exercise capacity.

Zykadia

Treatment of patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib.

Purixan

Maintenance therapy of acute lymphoblastic leukemia (ALL) as part of a combination regimen.

Sylvant

Multicentric Castleman’s disease (MCD) in adults who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

Alprolix

Prevention and control of bleeding in hemophilia B.

Ragwitek

Short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by a (+) skin test or in vitro testing for pollen-specific IgE antibodies.

Hetlioz

Treatment of non-24-hour sleep-wake disorder (Non-24).

New Products

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.