Aspirin/omeprazole 81/40

Drug Profile

Aspirin/omeprazole 81/40

Alternative Names: Enteric-coated aspirin 81mg/immediate-release omeprazole 40mg - POZEN; PA-8140; Yosprala 81/40

Latest Information Update: 06 Oct 2016

Price : $50

At a glance

  • Originator POZEN
  • Developer Aralez Pharmaceuticals Inc.
  • Class 2 pyridinylmethylsulfinylbenzimidazoles; Antiplatelets; Antipyretics; Antirheumatics; Antiulcers; Benzimidazoles; Gastric antisecretories; Non-opioid analgesics; Salicylates; Small molecules
  • Mechanism of Action Cyclooxygenase inhibitors; Nitric oxide stimulants; Platelet aggregation inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Cardiovascular disorders

Most Recent Events

  • 03 Oct 2016 Launched for Cardiovascular disorders (Prevention of relapse) in USA (PO)
  • 14 Sep 2016 Registered for Cardiovascular disorders (Prevention of relapse) in USA (PO) (US FDA website)
  • 13 May 2016 Changed US FDA NDA acceptance date and PDUFA date to 25-03-2016 as per MR 9195740
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