Pii to Manufacture FDA-approved Bretylium Tosylate Injection Drug Product
Pharmaceutics International announced its partner, Academic Pharmaceuticals, Inc., received FDA approval of Bretylium Tosylate Injection USP, 500 mg/10 mL (50 mg/mL) Single-Dose Vials on December 21, 2018. Bretylium Tosylate Injection 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. Pii 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 U.S.
“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, 500 mg/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 sterilized vials, aseptically filled vials, and syringe products,” said Dr. Syed Abidi, Pii’s Chairman and CEO. “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,” added Dr. John Somberg, President of Academic Pharmaceuticals, Inc.