Research & Development
Academic Pharmaceuticals receives FDA approval for Bretylium Tosylate Injection
10 January 2019 -

Academic Pharmaceuticals Inc, the partner of Pharmaceutics International Inc, has received US Food and Drug Administration (FDA) approval for Bretylium Tosylate Injection USP, 500mg/10mL (50 mg/mL) Single-Dose Vials, it was reported yesterday.

The product is indicated for the prophylaxis and therapy of ventricular fibrillation; treatment of life-threatening ventricular arrhythmia that has failed to respond to first-line antiarrhythmic agents. Pharmaceutics International Inc is the exclusive manufacturer of Bretylium Tosylate for Academic Pharmaceuticals Inc, which is presently seeking a commercial partner to license and launch the drug product in the US.

Dr John Somberg, president of Academic Pharmaceuticals Inc, said, 'We are pleased to gain approval of this additional therapy to treat ventricular fibrillation offering health care providers alternative options to treat this life-threatening condition. Bretylium Tosylate Injection USP, 500mg/10 mL is the 11th FDA product approval and 3rd injectable product approval, for Pii and its partners, during the past two years. This most recent approval follows the tentative approval of the first syringe product filed from Pii, thus expanding Pii's injectable product offering to include terminally sterilised vials, aseptically filled vials, and syringe products.'

Dr Syed Abidi, Pii's chairman and CEO, added, 'Bretylium Tosylate is a uniquely effective agent for the treatment of ventricular tachycardia and ventricular fibrillation in a cardiac arrest. It is the only drug that can pharmacologically convert ventricular fibrillation, it is an alternative to Amiodarone and more effective than Lidocaine.'