FDA Approves First Brilinta Generic

The US Food and Drug Administration (FDA) has approved the first generic medication indicated for lowering the risk of heart attack, or death from heart attack or stroke in patients with acute coronary syndrome (ACS).

The US Food and Drug Administration (FDA) has approved the first generic medication indicated for lowering the risk of heart attack, or death from heart attack or stroke in patients with acute coronary syndrome (ACS).

Ticagrelor tablets, a generic version of Brilinta from AstraZeneca Pharmaceuticals, have been granted Abbreviated New Drug Application (ANDA) approval in 60 mg and 90 mg doses. According to the FDA, the ANDA applicant company was Watson Laboratories, Inc, a subsidiary of Teva Pharmaceuticals.

Brilinta was first approved by the FDA in September 2015 as an oral 60 mg tablet. As a direct-acting P2Y12receptor agonist, ticagrelor functions by inhibiting platelet aggregation in patients with ACS or ST elevation.

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