Most Read Articles
05 Mar 2017
Lymphoma of the eyelid mostly comprises several lymphoma subtypes, with histological subtype being the main predictor of outcome, according to a study.

Original New Drug Application Approvals by US FDA (16 - 31 May 2017)

31 May 2017
New drug applications approved by US FDA as of 16 - 31 May 2017 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

JADENU SPRINKLE
  • Active Ingredient(s): DEFERASIROX
  • Strength: 90MG; 180MG
  • Dosage Form: Oral granule
  • Company: Novartis Pharms Corp
  • Approval Date: May 18, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for
    • the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older
    • the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L
  • Approved Label: 05/18/2017 (PDF)

KEVZARA
  • Active Ingredient(s): SARILUMAB
  • Strength: 150MG/1.14ML; 200MG/1.14ML
  • Dosage Form: Injectable; Injection
  • Company: Sanofi Synthelabo
  • Approval Date: May 22, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
  • Approved Label: 05/22/2017 (PDF)

ZERVIATE
  • Active Ingredient(s): CETIRIZINE HYDROCHLORIDE
  • Strength: EQ 0.24% BASE
  • Dosage Form: Ophthalmic solution/drops
  • Company: Nicox Ophthalmics
  • Approval Date: May 30, 2017
  • Chemical Type: Type 3 - New Dosage Form
  • Indication(s): Indicated for treatment of ocular itching associated with allergic conjunctivitis
  • Approved Label: 05/30/2017 (PDF)
Editor's Recommendations
Most Read Articles
05 Mar 2017
Lymphoma of the eyelid mostly comprises several lymphoma subtypes, with histological subtype being the main predictor of outcome, according to a study.