APP launches amiodarone hydrochloride in liquid form
LOS ANGELES, CAL., Oct. 17, 2002 -- American Pharmaceutical Partners (APP) has begun marketing and selling amiodarone hydrochloride injection in 150mg strength, 3mL single-dose vials.
Approval from the FDA for the Abbreviated New Drug Application (ANDA) for this product was received October 15, 2002.
Amiodarone hydrochloride is indicated for the initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy, and is the generic equivalent of Wyeth Pharmaceuticals' Cordarone I.V.
As with all new APP products, amiodarone hydrochloride will be bar coded in an effort to reduce the possibility of administration error.
"Amiodarone hydrochloride is one of the most widely used drugs in the cardiovascular critical care setting," said Patrick Soon-Shiong, M.D., chairman, president and chief executive officer of APP. "With the addition of amiodarone, APP now sells 33 critical care products in 81 separate dosages and formulations.
American Pharmaceutical Partners is a specialty drug company that develops, manufactures and markets a growing portfolio of injectable pharmaceutical products; focusing on the oncology, anti-infective and critical care markets. The company is one of the largest producers of injectable pharmaceuticals, with more than 110 generic products in more than 350 dosages and formulations.
Source: American Pharmaceutical Partners www.appdrugs.com
Posted: October 2002