Health & Medicine
Generic Drug Doxil Approved to Help Cancer Patients
Kathleen Lees
First Posted: Feb 05, 2013 10:54 AM EST
A generic version of the cancer drug Doxil has been approved that could help with a drug shortage that has threatened many patients lives.
As of Monday, the Food and Drug Administration approved the drug, known generically as doxorubicin HCI liposome injection, that is made by Sun Pharma Global FZE, a subsidiary of India's Sun Pharmaceutical Industries Ltd. It will be available in 20 milligram and 50 milligram vials.
The product is the first generic version of Doxil, (which is made by Johnson and Johnson) which was originally approved in 1995 and used to treat ovarian cancer, AIDS-related Kaposi's sarcoma and multiple myeloma.
Unfortunately, Doxil started running out of supplies at an outside contract manufacturer, Ben Venue Laboratories Inc, a unit of German drug maker Boehringer Ingelheim, and suspended operations in November 2011 due to the quality control problems.
Last February, the FDA allowed for the temporary importation of Lipodox, made by Sun Pharmaceutical Industries Ltd. and contains the same active ingredients as Doxil. The agency said it intends to continue allowing the importation of the product until Sun has made enough generic Doxil to meet demand.
It wasn't until late last month that a federal judge approved a consent decree under which Ben Venue must bring its Bedford, Ohio facility into compliance with regulatory requirements or face fines and other penalties.
The FDA said the company had repeatedly violated manufacturing practices, and recent inspections found that poorly maintained equipment had deteriorated to the point that particles were shedding into inject-able drugs, according to the FDA.
As the generic drug provides promising hopes for the future, researchers hope that this and other generics can help ease the shortages of much needed prescription drugs.
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First Posted: Feb 05, 2013 10:54 AM EST
A generic version of the cancer drug Doxil has been approved that could help with a drug shortage that has threatened many patients lives.
As of Monday, the Food and Drug Administration approved the drug, known generically as doxorubicin HCI liposome injection, that is made by Sun Pharma Global FZE, a subsidiary of India's Sun Pharmaceutical Industries Ltd. It will be available in 20 milligram and 50 milligram vials.
The product is the first generic version of Doxil, (which is made by Johnson and Johnson) which was originally approved in 1995 and used to treat ovarian cancer, AIDS-related Kaposi's sarcoma and multiple myeloma.
Unfortunately, Doxil started running out of supplies at an outside contract manufacturer, Ben Venue Laboratories Inc, a unit of German drug maker Boehringer Ingelheim, and suspended operations in November 2011 due to the quality control problems.
Last February, the FDA allowed for the temporary importation of Lipodox, made by Sun Pharmaceutical Industries Ltd. and contains the same active ingredients as Doxil. The agency said it intends to continue allowing the importation of the product until Sun has made enough generic Doxil to meet demand.
It wasn't until late last month that a federal judge approved a consent decree under which Ben Venue must bring its Bedford, Ohio facility into compliance with regulatory requirements or face fines and other penalties.
The FDA said the company had repeatedly violated manufacturing practices, and recent inspections found that poorly maintained equipment had deteriorated to the point that particles were shedding into inject-able drugs, according to the FDA.
As the generic drug provides promising hopes for the future, researchers hope that this and other generics can help ease the shortages of much needed prescription drugs.
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone