New Delhi: Drug firm Alembic Pharmaceuticals has received tentative approval from the US health regulator for Ticagrelor tablets, used to reduce the rate of cardiovascular death and stroke in patients with the acute coronary syndrome (ACS) or a history of myocardial infarction (MI).
“The company has got tentative approval from the US Food and Drug Administration (USFDA) to market the drug in the strength of 90 mg,” Alembic Pharmaceuticals said in a BSE filing.
The tentatively approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD), Brilinta tablets of AstraZeneca Pharmaceuticals LP.
Quoting IQVIA sales data, the company said, Ticagrelor tablets, 90 mg had an estimated market size of USD 625 million for 12 months, ending December 2017.
The company said it now has a total of 75 ANDA approvals from the USFDA.