Alembic receives US FDA tentative approval for Ticagrelor Tablets, 90 mg

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Ticagrelor tablets are indicated to reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with ACS or a history of Ml

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company has announced that the company has received tentative approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) Ticagrelor Tablets, 90 mg.

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Brilinta Tablets, 90 rng, of Astrazeneca Pharmaceuticals. Ticagrelor tablets are indicated to reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction (Ml).

Ticagrelor Tablets, 90 mg have an estimated market size of US $ 625 million for twelve months ending December 2017 according to IQVIA. Alembic now has a total of 75 ANDA approvals (65 final approvals and 10 tentative approvals) from US FDA.