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New drug applications approved by US FDA as of 01 - 15 June 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. 

Original New Drug Application Approvals by US FDA (1 - 15 September 2016)

15 Sep 2016
New drug applications approved by US FDA as of 1 - 15 September 2016 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.

YOSPRALA
  • Active Ingredient(s): Aspirin; Omeprazole
  • Strength: 81MG/40MG; 325MG/40MG
  • Dosage Form: Delayed-release oral tablet
  • Company: Aralez Pharms INC
  • Approval Date: September 14, 2016
  • Chemical Type: Not available
  • Indication(s): The aspirin component of YOSPRALA is indicated for:
    • reducing the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli,
    • reducing the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina pectoris,
    • reducing the combined risk of MI and sudden death in patients with chronic stable angina pectoris,
    • use in patients who have undergone revascularization procedures (Coronary Artery Bypass Graft [CABG] or Percutaneous Transluminal Coronary Angioplasty [PTCA]) when there is a pre-existing condition for which aspirin is already indicated.

    The omeprazole component of YOSPRALA is indicated for:
    • decreasing the risk of developing aspirin associated gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers due to age (≥ 55) or documented history of gastric ulcers
  • Approved Label: 09/14/2016 (PDF)
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Most Read Articles
21 Jun 2016
Sofosbuvir-based regimens showed good cost-effectiveness in a majority of patients suffering from chronic hepatitis C, as observed in a systematic review of fourteen studies conducted in seven different countries.
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