Unichem Labs irregular heartbeat drug Amiodarone gets USFDA approval
Mumbai: Unichem Laboratories Limited has received ANDA approval for its Amiodarone Tablets, USP, 200 mg from the United States Food and Drug Administration (USFDA) to market a generic version of CORDARONE® (amiodarone) tablets of Wyeth Pharmaceuticals Inc.
Amiodarone tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated.
The product will be commercialized from Unichem's Ghaziabad Plant.
Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world.