eptifibatide
Drug Details
- Generic Name
- eptifibatide
- Brand Names
- Eptifibatide, eptifibatide
- Application Number
- ANDA203258
- Sponsor
- Mylan Institutional LLC
- NDC Codes
- 13
- Dosage Forms
- INJECTION, SOLUTION, INJECTION
- Routes
- INTRAVENOUS
- Active Ingredients
- EPTIFIBATIDE
Indications and Usage
1 INDICATIONS AND USAGE Eptifibatide injection is a platelet aggregation inhibitor indicated for: • Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) ( 1.1 ) • Treatment of patients undergoing PCI (including intracoronary stenting) ( 1.2 ) 1.1 Acute Coronary Syndrome (ACS) Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (MI) in patients with ACS (unstable angina [UA]/non-ST- elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). 1.2 Percutaneous Coronary Intervention (PCI) Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new MI, or need for urgent intervention in patients undergoing PCI, including those undergoing intracoronary stenting [see Clinical Studies (14.1 , 14.2) ] .