FDA said it will allow Lipodox, which is made by Sun Pharma Global FZE and distributed by Caraco Pharmaceutical Laboratories, to be imported into the U.S. as an alternative to Doxil. The drugs have the same active ingredient. FDA said Doxil is used in multiple treatment regimens, including treatment of ovarian cancer after failure of platinum-based chemotherapy. The drug is also indicated for use in AIDS-related Kaposi's sarcoma and multiple myeloma.
"FDA anticipates that the incoming supply of Lipodox will be able to fully meet patient needs," the agency said in a statement.
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21 febrero 2012
LipoDOX substituye al Doxil . FDA To OK Temporary Replacement Drug For J&J's Doxil .
DOW JONES NEWSWIRES
The Food and Drug Administration is set to announce Tuesday it will allow the temporary importation of a drug made by an Indian company to help offset a shortage of Johnson & Johnson's (JNJ) cancer drug Doxil, USA Today reported Monday on its website, citing an official with the agency.
The importation of Lipodox, made by Sun Pharma Global, will deal with the shortage of Doxil "for the foreseeable future," the FDA's Sandra Kweder said in an interview.
Doxil is used to treat patients with ovarian cancer and other tumors.
Full story at: http://yourlife.usatoday.com/health/story/2012-02-20/New- source-found-for-cancer-drug-Doxil-in-short-supply/53181806/1
The Food and Drug Administration is set to announce Tuesday it will allow the temporary importation of a drug made by an Indian company to help offset a shortage of Johnson & Johnson's (JNJ) cancer drug Doxil, USA Today reported Monday on its website, citing an official with the agency.
The importation of Lipodox, made by Sun Pharma Global, will deal with the shortage of Doxil "for the foreseeable future," the FDA's Sandra Kweder said in an interview.
Doxil is used to treat patients with ovarian cancer and other tumors.
Full story at: http://yourlife.usatoday.com/health/story/2012-02-20/New- source-found-for-cancer-drug-Doxil-in-short-supply/53181806/1
Doxil , La FDA ha encontrado en la India un Farmaco para Substituir al DOXIL Temporalmente ... el LipoDOX . ( USA Today ) .
Replacement found for cancer drug Doxil, in short supply .
Patients with ovarian cancer and other deadly tumors will regain access to an important chemotherapy drug, Food and Drug Administration officials told USA TODAY in an exclusive interview Monday.
The drug, Doxil, has been in short supply since last June. There are no generic versions of the drug, which is also used to treat multiple myeloma and AIDS-related Kaposi's sarcoma.
The agency says it will announce today that it has worked out a deal to temporarily import a replacement drug, called Lipodox, from an Indian company, says the FDA's Sandra Kweder. The FDA has previously inspected the company, Sun Pharma Global, which exports the drug to other companies.
"It's wonderful news," says Kweder, who says the deal will address the Doxil shortage "for the forseeable future."
Doxil is one of 287 drugs that have been in short supply this year, says the University of Utah's Drug Information Service, which has been monitoring the problem. That's up from 61 shortages in 2005, the FDA says.
...
Patients with ovarian cancer and other deadly tumors will regain access to an important chemotherapy drug, Food and Drug Administration officials told USA TODAY in an exclusive interview Monday.
The drug, Doxil, has been in short supply since last June. There are no generic versions of the drug, which is also used to treat multiple myeloma and AIDS-related Kaposi's sarcoma.The agency says it will announce today that it has worked out a deal to temporarily import a replacement drug, called Lipodox, from an Indian company, says the FDA's Sandra Kweder. The FDA has previously inspected the company, Sun Pharma Global, which exports the drug to other companies.
"It's wonderful news," says Kweder, who says the deal will address the Doxil shortage "for the forseeable future."
Doxil is one of 287 drugs that have been in short supply this year, says the University of Utah's Drug Information Service, which has been monitoring the problem. That's up from 61 shortages in 2005, the FDA says.
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