Alembic Pharmaceuticals gets USFDA tentative approval for ANDA Ticagrelor Tablets, 90 mg

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) 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 mg, of Astrazeneca Pharmaceuticals LP. 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).

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