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Rachel Soon, 5 days ago

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Jackey Suen, 08 Oct 2018

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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
Rachel Soon, 5 days ago

On 8 August, the first town hall held by the Ministry of Health (MOH) with members of the pharmacy profession took place in Putrajaya. Over 500 pharmacists from across the country and from different areas of practice—community and hospital, public and private, academy and industry—converged to fill the auditorium for the chance to engage in direct dialogue with MOH.

Jackey Suen, 08 Oct 2018

Adding pertuzumab to trastuzumab plus an aromatase inhibitor (AI) improves progression-free survival (PFS) in patients with HER2-positive metastatic or locally advanced breast cancer, the phase II PERTAIN study has shown.

05 Aug 2019
Use of alpha blockers in the treatment of hypertension in women is associated with an increased risk of hypotension and related events as compared with other blood pressure-lowering drugs, as reported in a recent study.
Laura Kho Sui San , 29 May 2019
Anxiety becomes a pathological disorder when it occurs for no detectable reason, persists and interferes with daily activities like work performance and relationships.