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22 Oct 2018
Transdermal androgen appears beneficial to ageing patients with sex hormone deficiency-associated dry eye, with a recent study showing that short-term treatment relieves both symptoms and signs of the condition, as well as improves quality of life (QOL). These benefits are achieved without increasing the incidence of serious side effects.

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
22 Oct 2018
Transdermal androgen appears beneficial to ageing patients with sex hormone deficiency-associated dry eye, with a recent study showing that short-term treatment relieves both symptoms and signs of the condition, as well as improves quality of life (QOL). These benefits are achieved without increasing the incidence of serious side effects.