Research & Development
Pii wins US FDA's approval for Bretylium Tosylate Injection for ventricular fibrillation
10 January 2019 -

cGMP manufacturing services company Pharmaceutics International Inc (Pii) reported on Wednesday the receipt of the US FDA approval for Bretylium Tosylate Injection in USP 500 mg/10 mL (50 mg/mL) Single-Dose Vials for the treatment of ventricular fibrillation.

On 21 December 2018, the US FDA's approval was awarded to the company's partner, Academic Pharmaceuticals Inc.

The company said Bretylium Tosylate Injection is indicated for the prophylaxis and therapy of ventricular fibrillation as well as for the treatment of life-threatening ventricular arrhythmia that has failed to respond to first-line antiarrhythmic agents.

In conjunction, the company is the exclusive manufacturer of Bretylium Tosylate for Academic Pharmaceuticals Inc, who is currently seeking a commercial partner to license and launch the drug product in the US.

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