FDA Approval Activities for this Drug…

Integrilin (eptifibatide) Injection, 20 mg/10 ml and 75 mg/ 100 ml, Injection, COR Therapeutics NDA 20-718 5/18 5/28/98 5/28/98 1/2/02 Integrilin Indications: 1. For the treatment of patients with acute coronary syndrome (UA/NQMI), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). In this setting, INTEGRILIN has been shown to decrease the rate of a combined endpoint of death or new myocardial infarction. 2. For the treatment of patients undergoing PCI. In this setting, INTEGRILIN has been shown to decrease the rate of a combined endpont of death, new myocardial infarction, or need for urgent intervention. Integrilin (eptifibatide) Injection, COR Therapeutics, NDA 20-718/S-002 9/20/99 9/24/99 9/24/99 7/5/01 Integrilin Indication:For the treatment of patients with acute coronary syndrome (UA/NQMI), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). In this setting, Integrilin has been shown to decrease the rate of a combined endpoint of death or new myocardial infarction. For the treatment of patients undergoing PCI. In this setting, Integrilin has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction, or need for urgent intervention. Integrilin (eptifibatide) Injection, COR Therapeutics, NDA 20-718/S-010 & S-13 EPTIFIBATIDE Injection 2MG/ML INTEGRILIN MILLENNIUM 020718 EPTIFIBATIDE Injection 75MG/100ML INTEGRILIN MILLENNIUM Integrilin (eptifibatide) Injection, Millennium Pharmaceuticals, Inc., Labeling Revision

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