Most Read Articles
Pearl Toh, 4 days ago
Every-two-month injections of the long-acting cabotegravir + rilpivirine were noninferior to once-monthly injections for virologic suppression at 48 weeks in people living with HIV*, according to the ATLAS-2M** study presented at CROI 2020 — thus providing a potential option with more convenient dosing.
Stephen Padilla, 19 Mar 2020
The assumption that children are less vulnerable to the coronavirus disease 2019 (COVID-19) compared to adults is not quite true and may even be dangerous, suggests a recent study.
22 Mar 2020
Sustained use of lopinavir-combined regimen appears to confer benefits among patients with the novel coronavirus disease (COVID-19), with improvement possibly indicated by increasing eosinophils, suggests a recent study.
24 Mar 2020
COVID-19 is a novel disease, with no existing immunity. The virus can be transmitted from person to person, quickly and exponentially. Here’s what we can do to slow down the spread, if not contain the outbreak.

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
Pearl Toh, 4 days ago
Every-two-month injections of the long-acting cabotegravir + rilpivirine were noninferior to once-monthly injections for virologic suppression at 48 weeks in people living with HIV*, according to the ATLAS-2M** study presented at CROI 2020 — thus providing a potential option with more convenient dosing.
Stephen Padilla, 19 Mar 2020
The assumption that children are less vulnerable to the coronavirus disease 2019 (COVID-19) compared to adults is not quite true and may even be dangerous, suggests a recent study.
22 Mar 2020
Sustained use of lopinavir-combined regimen appears to confer benefits among patients with the novel coronavirus disease (COVID-19), with improvement possibly indicated by increasing eosinophils, suggests a recent study.
24 Mar 2020
COVID-19 is a novel disease, with no existing immunity. The virus can be transmitted from person to person, quickly and exponentially. Here’s what we can do to slow down the spread, if not contain the outbreak.