Alembic Pharma receives USFDA nod for drug for patients with acute coronary syndrome

Alembic Pharmaceuticals Ltd. on Wednesday, October 29, said it has received the US Food and Drug Administration’s (USFDA) final approval for its abbreviated new drug application (ANDA) for the Ticagrelor tablets, 60mg.The tablets are to reduce the risk of cardiovascular death, myocardial infarction (MI) and stroke in patients with acute coronary syndrome (ACS) or a history of MI, the company said, adding that for at least the first 12 months following ACS, it is superior to clopidogrel.

The approved ANDA is therapeutically equivalent to the reference-listed drug Brilinta Tablets, 60 mg, of AstraZeneca Pharmaceuticals LP.

Alembic Pharma said the tablets also reduce 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 at high risk for such events, and to reduce the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack.
The tablets have an estimated market size of $236 million for 12 months ending June 2025, as per the IQVIA.Alembic Pharma said it had previously received final approval for the tablets in the 90mg strength.

The company has a total of 227 ANDA approvals from the USFDA. Of these, 206 are final approvals and 21 are tentative approvals.

Alembic Pharma shares were trading flat at ₹905.15 apiece around 12.20 pm on Wednesday. The stock has declined 13.7% this year, so far.

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