ticagrelor
ticagrelor is listed in the FDA National Drug Code directory with 9 NDC codes, marketed under brand names including ticagrelor, TICAGRELOR. Available dosage forms: tablet, tablet, film coated, powder.
Drug Details
- Generic Name
- ticagrelor
- Brand Names
- ticagrelor, TICAGRELOR
- Application Number
- ANDA218962
- Sponsor
- ScieGen Pharmaceuticals INC
- NDC Codes
- 9
- Dosage Forms
- TABLET, TABLET, FILM COATED, POWDER
- Routes
- ORAL
- Active Ingredients
- TICAGRELOR
Indications and Usage
1 INDICATIONS AND USAGE Ticagrelor is a P2Y 12 platelet inhibitor indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. ( 1.1 ) to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of Ticagrelor was established in a population with type 2 diabetes mellitus (T2DM). ( 1.2 ) to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). ( 1.3 ) 1.1 Acute Coronary Syndrome or a History of Myocardial Infarction Ticagrelor tablets are indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor tablets also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS [see Clinical Studies ( 14.1 )]. 1.2 Coronary Artery Disease but No Prior Stroke or Myocardial Infarction Ticagrelor tablets are indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events [see Clinical Studies ( 14.2 )]. While use is not limited to this setting, the efficacy of ticagrelor tablets were established in a population with type 2 diabetes mellitus (T2DM). 1.3 Acute Ischemic Stroke or Transient Ischemic Attack (TIA) Ticagrelor tablet is indicated to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA) [see Clinical Studies ( 14.3 )].