06 November 2013 | News | By BioSpectrum Bureau
The FDA believes that this approval of the first generic version of the cancer drug will help resolve the shortage triggered by manufacturing deficiencies
Singapore: The US FDA has provided its approval for a generic version of cancer drug Doxil that has been facing shortage due to manufacturing deficiencies.
This generic version of the drug called doxorubicin is to be made by Sun Pharma Global. The federal regulators have said that this approval of the first generic version of the cancer drug will help resolve a lingering shortage triggered by manufacturing deficiencies.
The shortage of the Johnson and Johnson (J&J) injectable medication has continued on and off for a few years. It has resulted in rationing, with some patients with ovarian and other cancers getting less-effective care and disrupted studies testing Doxil against possible new treatments.
Last February, the FDA authorized temporary importation from India of a brand-name version of the drug called Lipodox, which is also made by Sun Pharma. The company is a subsidiary of Indian drug maker Sun Pharmaceutical Industries.