FDA: First Generic Version of Cancer Drug Doxil Approved
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(HealthDay News) -- The first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection) has been approved by the U.S. Food and Drug Administration, which says the action should help relieve shortages of the brand-name medication.
Doxil is on the agency's drug shortage list. The list empowers the FDA's Office of Generic Drugs to grant priority review to generic equivalents, the agency said Monday in a news release.
Noting that generics were of the same quality and strength as the original drugs, the FDA said: "Generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs."
Generic Doxil will be produced by Sun Pharma Global FZE in 20 milligram and 50 milligram vials. The brand-name drug is produced by Janssen Pharmaceuticals.