Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets, 60 mg.
The approved product is therapeutically equivalent to Brilinta Tablets, 60 mg of AstraZeneca Pharmaceuticals LP. Ticagrelor is indicated to reduce the risk of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction, and to lower the risk of stent thrombosis, coronary artery disease events, and certain strokes or transient ischemic attacks.
According to IQVIA, Ticagrelor Tablets, 60 mg, have an estimated market size of USD 236 million for the 12 months ending June 2025. Alembic had earlier received USFDA approval for Ticagrelor Tablets, 90 mg, bringing its total ANDA approvals to 227 (206 final and 21 tentative).