USFDA29 Oct 2025, 12:00 pm
Alembic Pharmaceuticals Receives USFDA Final Approval for Ticagrelor Tablets, 60 mg
AI Summary
Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) 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. Ticagrelor tablets are indicated for reducing the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI, and more. The estimated market size of Ticagrelor Tablets, 60 mg, is US$ 236 million for twelve months ending June 2025 according to IQVIA.
Key Highlights
- Alembic Pharmaceuticals Limited receives USFDA Final Approval for Ticagrelor Tablets, 60 mg.
- Ticagrelor Tablets, 60 mg, are indicated for reducing the risk of CV death, MI, and stroke in patients with ACS or a history of MI, and more.
- The estimated market size of Ticagrelor Tablets, 60 mg, is US$ 236 million for twelve months ending June 2025 according to IQVIA.
- Alembic Pharmaceuticals Limited has previously received final approval for Ticagrelor Tablets, 90 mg.
- Alembic has a cumulative total of 227 ANDA approvals (206 final approvals and 21 tentative approvals) from USFDA.