The Food and Drug Administration (FDA) has approved the Prior Approval Supplement for Bretylium Tosylate Injection, allowing ANI Pharmaceuticals to market the once discontinued antiarrhythmic agent.

Bretylium Tosylate Injection 500mg/10mL is indicated in the prophylaxis and therapy of ventricular fibrillation. It is also indicated in the treatment of life-threatening ventricular arrhythmias, such as ventricular tachycardia, that have failed to respond to adequate doses of a first-line antiarrhythmic agent, such as lidocaine. Its use should be limited to intensive care units, coronary care units or other facilities properly equipped to monitor for cardiac arrhythmias and blood pressure.

Prior to the discontinuation of Bretylium Tosylate in 1999 due to a shortage in raw material, it was readily stocked as a standard drug on crash carts. The limited availability of the product prompted a review of evidence supporting its continued use that led to the subsequent removal of the product from the American Heart Association’s Advanced Cardiovascular Life Support treatment algorithms and guidelines based on the high occurrence of adverse effects and the availability of safer products.

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ANI Pharmaceuticals plans to launch the product in December 2019. 

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