New Drug Product Slideshows

Anoro Ellipta

Long-term maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and/or emphysema.

Tretten

Routine prophylaxis of bleeding in patients with congenital factor XIII (FXIII) A-subunit deficiency.

Vimizim

Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).

Otrexup

Management of adults with severe, active rheumatoid arthritis (RA) or children with active polyarticular juvenile idiopathic arthritis (pJIA).

Zohydro ER

Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Duavee

Treatment of moderate-to-severe vasomotor symptoms associated with menopause. Prevention of postmenopausal osteoporosis.

Imbruvica

Treatment of patients with mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.

Farxiga

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

New Products

OTEZLA

  • 4/20/2014
  • Celgene Corp
  • Apremilast 10mg, 20mg, 30mg; tablets.
  • Treatment of adults with active psoriatic arthritis.

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.
IMBRUVICA

IMBRUVICA

  • 3/2/2014
  • Pharmacyclics and Janssen Biotech
  • Ibrutinib 140mg; caps.
  • Treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Both indications are based on overall response rate. An improvement in survival or disease-related symptoms has not been established.
FARXIGA

FARXIGA

  • 2/23/2014
  • BristolMyers Squibb and AstraZeneca
  • Dapagliflozin 5mg, 10mg; tablets.
  • Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitation of use: not for treating type 1 diabetes mellitus or diabetic ketoacidosis.
GAZYVA

GAZYVA

  • 2/16/2014
  • Genentech, Inc.
  • Obinutuzumab 25mg/mL; soln for IV infusion after dilution; preservative-free.
  • Treatment of patients with previously untreated chronic lymphocytic leukemia (CLL), in combination with chlorambucil.
SOVALDI

SOVALDI

  • 2/9/2014
  • Gilead Sciences, Inc.
  • Sofosbuvir 400mg; tabs.
  • As a component of a combination antiviral treatment regimen for chronic hepatitis C (CHC) genotype 1, 2, 3, or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplant), and those with HCV/HIV-1 co-infection. Not for use as monotherapy.
OLYSIO

OLYSIO

  • 2/2/2014
  • Janssen Therapeutics
  • Simeprevir 150mg; caps.
  • Chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in patients with compensated liver disease, including cirrhosis. Not for use as monotherapy. Screen for presence of virus with NS3Q80K polymorphism at baseline; consider alternative therapy if Q80K polymorphism is present.
FYCOMPA

FYCOMPA

  • 1/26/2014
  • Eisai Pharmaceuticals
  • Perampanel 2mg, 4mg, 6mg, 8mg, 10mg, 12mg; tabs.
  • Adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients ≥12 years of age.
BRINTELLIX

BRINTELLIX

  • 1/19/2014
  • Takeda and Lundbeck
  • Vortioxetine 5mg, 10mg, 20mg; tabs.
  • Treatment of adults with major depressive disorder (MDD).
SURFAXIN

SURFAXIN

  • 1/12/2014
  • Discovery Laboratories, Inc.
  • Lucinactant 8.5mL/vial; contains phospholipids 30mg (dipalmitoylphosphatidylcholine 22.5mg, palmitoyloleoyl-phosphatidylglycerol 7.5mg, sodium salt), palmitic acid 4.05mg, sinapultide 0.862mg; per mL; susp for intratracheal administration; preservative-free.
  • For the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS.
ADEMPAS

ADEMPAS

  • 12/15/2013
  • Bayer Healthcare Pharmaceuticals Inc.
  • Riociguat 0.5mg, 1mg, 1.5mg, 2mg, 2.5mg; tabs.
  • Treatment of persistent/recurrent chronic thromboembolic ­pulmonary hypertension (CTEPH), (Who Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class. Pulmonary arterial hypertension (PAH), (Who Group 1) to improve exercise capacity, WHO functional class, and to delay clinical worsening.
BRISDELLE

BRISDELLE

  • 12/8/2013
  • Noven Therapeutics
  • Paroxetine (as mesylate) 7.5mg; capsules.
  • Moderate to severe vasomotor symptoms associated with menopause. Limitation of use: not indicated for treatment of any psychiatric condition.
OPSUMIT

OPSUMIT

  • 12/1/2013
  • Actelion Pharmaceuticals
  • Macitentan 10mg; tabs.
  • Treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to delay disease progression. In clinical studies, treatment delayed disease progression (death, initiation of IV or SC prostanoids, or clinical worsening of PAH [decreased 6MWD, worsened PAH symptoms and need for additional PAH treatment]) and reduced hospitalization for PAH.
VALCHLOR

VALCHLOR

  • 11/24/2013
  • Actelion Pharmaceuticals
  • Mechlorethamine 0.016%; topical gel; contains propylene glycol, isopropyl alcohol.
  • Treatment of Stage IA and IB mycosis fungoides-type ­cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy.
GRANIX

GRANIX

  • 11/17/2013
  • Teva Pharmaceuticals
  • Tbo-filgrastim 300mcg/0.5mL, 480mcg/0.8mL; soln for SC inj; preservative-free.
  • To reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.