Alembic Pharma Gets USFDA Nod For Ticagrelor Tablets

Alembic Pharmaceuticals Ltd. said Friday it has received final approval from the US Food and Drug Administration for 90 mg ticagrelor tablets, and tentative approval for the 60 mg variant.

The drug is used to lower the risk of cardiovascular death, heart attack, and stroke in patients with coronary artery disease, and also reduces the risk of stent thrombosis in those treated for acute coronary syndrome.

Alembic said the product is therapeutically equivalent to AstraZeneca’s Brilinta tablets. According to IQVIA, the 90 mg version has an estimated market size of $1,062 million and the 60 mg version $242 million for the year ended March.

With this, Alembic has secured 222 ANDA approvals from the USFDA, including 197 final and 25 tentative nods.