US APP gets tentative FDA okay for generic 'Paraplatin'

10 June 2002 17:14  [Source: ICIS news]

HOUSTON (CNI)--American Pharmaceutical Partners (APP) said Monday it has received tentative approval from the US Food and Drug Administration (FDA) on its abbreviated new drug application (ANDA) for its generic equivalent of Bristol-Myers Squibb (BMS)’s ovarian cancer drug Paraplatin.

The Los Angeles, California-based company said it received approval for 50 mg, 150 mg and 450 mg injections of carboplatin - the chemical name for Paraplatin.

Patrick Soon-Shiong, chairman, president and chief executive officer of APP, said sales of carboplatin were nearly $480m (Euro510.6m) in 2001 and have more than doubled over the last five years.

He added: "Carboplatin is an important oncology compound and we are pleased to add it to our future product offering."

APP will not receive final approval from the FDA until BMS's patent protection expires in 2004, the company said.

American Pharmaceutical Partners is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets.


By: Mike Sheridan
+1 713 525 2653



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