Prasugrel
Prasugrel is listed in the FDA National Drug Code directory with 14 NDC codes, marketed under brand name including Prasugrel. Available dosage form: tablet, film coated.
Drug Details
- Generic Name
- Prasugrel
- Brand Names
- Prasugrel
- Application Number
- ANDA205927
- Sponsor
- Mylan Pharmaceuticals Inc.
- NDC Codes
- 14
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- PRASUGREL HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Prasugrel is a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: • Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) ( 1.1 ). • Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI ( 1.1 ). 1.1 Acute Coronary Syndrome Prasugrel tablets are indicated to reduce the rate of thrombotic CV events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows: Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI). Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI. Prasugrel tablets has been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke compared to clopidogrel. The difference between treatments was driven predominantly by MI, with no difference on strokes and little difference on CV death [see Clinical Studies ( 14 )].