Original New Drug Application Approvals by US FDA (01 - 15 July 2019)

15 Jul 2019
Original New Drug Application Approvals by US FDA (01 - 15 July 2019)
New drug applications approved by US FDA as of 01 - 15 July 2019 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.

XPOVIO
  • Active Ingredient(s): Selinexor
  • Strength: 20 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Karyopharm Therapeutics Inc.
  • Approval Date: 03 July 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
  • Approved Label03 July 2019 (PDF)

KATERZIA
  • Active Ingredient(s): Amlodipine benzoate
  • Strength: 1 mg/mL
  • Dosage Form(s) / Route(s): Suspension; oral
  • Company: Silvergate Pharms
  • Approval Date: 08 July 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): May be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
    • Hypertension: indicated for the treatment of hypertension in adults and children 6 years and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily stroke and myocardial infarctions.
    • Coronary Artery Disease: Chronic Stable Angina; Vasospastic Angina (Prinzmetal's or Variant Angina); Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction <40%.
  • Approved Label08 July 2019 (PDF)
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