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Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) ticagrelor tablets, 60 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Brilinta tablets, 60 mg, of AstraZeneca Pharmaceuticals LP (AstraZeneca). 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; to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events, and iii) to reduce the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack (TIA). Refer label for a detailed indication.
Ticagrelor tablets, 60 mg, have an estimated market size of US$ 236 million for twelve months ending June 2025 according to IQVIA. Alembic had previously received final approval for ticagrelor tablets, 90 mg. The company has a cumulative total of 227 ANDA approvals (206 final approvals and 21 tentative approvals) from US FDA.
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