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Aurobindo cleared to market Tambocor generic

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DAYTON, N.J. — Aurobindo Pharma Ltd. has received final approval from the U.S. Food and Drug Administration for flecainide acetate tablets, a medication for irregular heartbeat.

Aurobindo said its product — available in dosages of 50 mg, 100 mg and 150 mg — is a generic equivalent of Tambocor tablets from Medicis (now part of Valeant Pharmaceuticals).

Flecainide acetate tablets are indicated for the prevention of paroxysmal supraventricular tachycardias (PSVT), episodes of rapid heart rate that start in a part of the heart above the ventricles, as well as for the prevention and treatment of certain severe, ventricular-related arrhythmias.

The drug had U.S. sales of approximately $67.3 million for the 12 months ended in April, according to IMS Health data reported by Aurobindo.


ECRM_06-01-22


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