Alembic Pharma Gets USFDA Nod for Ticagrelor Tablets

Alembic Pharmaceuticals Limited (Alembic) declares that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets, 60 mg.

The approved product is a functionally equivalent to the Brilinta Tablets, 60 mg, of AstraZeneca Pharmaceuticals LP, the reference listed drug (RLD).

Ticagrelor is an antiplatelet medication, which is part of the treatment aimed at decreasing the chances of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or those with a previous history of MI. In the first 12 months after an ACS event, it showed better results than clopidogrel. Besides, the drug alleviates the occurrence of stent thrombosis in patients who underwent stent placement for ACS.

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Moreover, Ticagrelor is recommended to reduce the risk of the first MI or stroke in patients with coronary artery disease (CAD) who are very risky, and also, to lessen the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score <5) or high-risk transient ischemic attack (TIA).

The approval made possible that Alembic could keep expanding its portfolio of cardiovascular therapy products and have more presence in the US generics market. The company is still committed to the development of complex generics and high-value formulations that help patients get affordable, quality ‍medicines.