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On August 26, Hanyu Pharmaceutical issued an announcement saying that it was recently learned through the official website of the State Food and Drug Administration that the company’s eptifibatide injection passed the consistency evaluation of the quality and efficacy of generic drugs, and the consistency of eptifibatide injection The status of the evaluation approved document (acceptance number: CYHB1950135) on the website of the State Food and Drug Administration has been changed to "drug approval certificate pending collection", and the date of issuance is August 18, 2021
The status of "drug approval certificate pending collection" means that the company's eptifibatide injection consistency evaluation has been approved by the State Food and Drug Administration, and the company has not yet received a formal drug approval
Indications of Etibatide Etibatide injection is used in patients with acute coronary syndrome (unstable angina pectoris/non-ST-segment elevation myocardial infarction), including patients receiving medical treatment and percutaneous coronary intervention Patients undergoing PCI to reduce the incidence of the combined endpoint of death or new myocardial infarction; for patients undergoing percutaneous coronary intervention (PCI), including patients undergoing coronary stenting