Monday, February 4, 2013

USFDA approves Sun Pharma's generic copy of Doxil

The U.S. Food and Drug Administration has approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection).  Doxil brand is owned by Johnson and Johnson.  The generic drug is manufactured by Sun Pharma Global  FZE, a subsidiary of Sun Pharma India. 

 Doxorubicin hydrochloride liposome injection is currently on the FDA’s drug shortage list.  Doxil fell into short supply after manufacturing problems at an outside contract manufacturer, Ben Venue Laboratories Inc, a unit of German drugmaker Boehringer Ingelheim, suspended operations in November 2011 due to quality control problems. Prior to when Doxil went into shortage, the world wide annual sales were $400m of which $140m came from the US.

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