The FDA has approved the first generic version of Doxil, Lipodox, the cancer drug made by Sun Pharma Global FZE. The drug comes in the form of a liposome injection in 20 milligram and 50 milligram vials, and administered by a health care professional, according to the government agency (February 4).
Doxil, added officials, is currently on the agency's drug shortage list, on which drugs are given expedited reviews to alleviate shortages:
"The agency is committed to doing everything we can to address drug shortages so that patients can get the medicines they need when they need them," said Capt. Valerie Jensen, R.Ph., director, Drug Shortage Staff, Center for Drug Evaluation and Research, FDA. "For the past year, the FDA has been working to ensure that supplies of doxorubicin HCl liposome injection were not interrupted."
FDA has also said that once Sun Pharma's production ramps up to a level where it can meet all the demand for this product, the regulator will stop Lipodox imports and also supplies made using any unapproved process.
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