Generic Version of Cancer Drug Doxil Approved by FDA

Doxil, an injection approved by the FDA to treat ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma, has been in short supply since November 2011.  A year and several months later, the FDA has finally approved a generic version of Doxil created by Sun Pharma Global FZE, a subsidiary of the Indian company Sun Pharmaceutical Industries.

The problem originated in the manufacturing plants of Ben Venue Laboratories due to quality control problems at its Bedford, Ohio facilities.  This exacerbated existing short supply of the drug.  Before making the move to approve the generic version of Doxil, the FDA temporarily allowed Sun Pharmaceutical to import Lipodox, another drug with the same active ingredient as Doxil, despite the fact that it was not FDA approved.  The FDA will continue to allow Lipodox on the market until supply of the generic catches up to demand.

In late January of 2013, Ben Venue became party to a consent decree under which it will be required to bring its facility into compliance with regulatory requirements and good manufacturing practices.  At this time, the facility is working in limited capacity, only manufacturing those drugs that the FDA deems essential for patient health.  Among past problems was the fact that deteriorated equipment was falling apart to the point where it was shedding particles into the injectable drugs.  Despite this, A U.S. House committee dedicated to addressing drug shortages blamed the FDA for being too aggressive in its action.

We think having access to safe pharmaceuticals is a basic right that should be available to all of us, especially those among us who are suffering due to chronic illnesses.  We don’t believe we should have to choose between access to such medicine, and the assurance of its safety.  If you have been injured by this or any other drug, contact a Kirkendall Dwyer LLP dangerous drug attorney to discuss the details of your case.

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