Alembic Pharmaceuticals 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 company stated that the approved ANDA is therapeutically equivalent to the reference listed drug Brilinta Tablets, 60 mg, of AstraZeneca Pharmaceuticals LP. Ticagrelor tablets are indicated to reduce the risk of cardiovascular death, myocardial infarction and stroke in patients with acute coronary syndrome or a history of myocardial infarction. For at least the first 12 months following acute coronary syndrome, Ticagrelor is noted to be superior to clopidogrel. The tablets also reduce the risk of stent thrombosis in patients who have undergone stenting for the treatment of acute coronary syndrome.
The product is further indicated to reduce the risk of a first myocardial infarction or stroke in patients with coronary artery disease at high risk for such events, and to reduce the risk of stroke in patients with acute ischaemic stroke (NIH Stroke Scale score <5) or high-risk transient ischaemic attack. The company has advised referring to the product label for detailed indications.
According to IQVIA, Ticagrelor Tablets, 60 mg, have an estimated market size of US$ 236 million for the 12 months ending June 2025.
Alembic previously received final approval for Ticagrelor Tablets, 90 mg. The company now has a cumulative total of 227 ANDA approvals from the USFDA, comprising 206 final approvals and 21 tentative approvals.