Mumbai, May 2 -- The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Brilinta Tablets (60 mg and 90 mg), of AstraZeneca Pharmaceuticals LP (AstraZeneca).
Ticagrelor tablets are indicated to:
i) 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. ii) Reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS. iii) Reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. iv) Reduce the risk of stroke in patients with acute ischemic str...