Doxil Generic Approved to Address Cancer Rx Shortage

FDA approves generic form of Doxil

(RxWiki News) Chemotherapy agents have been the hardest hit medications affected by ongoing drug shortages. The US Food and Drug Administration has approved a generic form of a commonly used medicine in an effort to resolve one shortage.

The FDA has approved a generic form of Doxil (doxorubicin hydrochloride liposome injection), a medication that’s currently on the agency’s “Drug Shortage List.” Lipodox (doxorubicin hydrochloride liposome injection) will be used as an alternative to Doxil.

Doxil is used in a variety of treatments, including treatment of ovarian cancer that has returned or gotten worse following platinum-based chemotherapy. The medication is also used to treat AIDS-related Kaposi's sarcoma and multiple myeloma. It costs about $1,200 per vial.

"Ask your pharmacist about supply shortages."

According to the FDA, generic drugs have the same quality and strength of brand name medications. Manufacturing and packaging facilities are inspected and must pass the same quality standards as brand name drugs.

Lipodox is not currently approved for use in the United States. The medication is produced by Sun Pharma Global and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd. 

Lipodox has been imported since February 2012 under the agency’s enforcement discretion for temporary controlled importation rules. Enforcement discretion was also used to release a single lot of Doxil made under an unapproved manufacturing process.

According to an FDA press release, “For the present time, FDA intends to continue exercising enforcement discretion for importation of Lipodox, and limited supplies of Doxil are available. Once supplies of Sun’s generic doxorubicin hydrochloride liposome injection are sufficient to meet projected demand, FDA expects to stop exercising enforcement discretion for any unapproved doxorubicin HCl liposomal product.”

 “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, RPh, director of the FDA's Drug Shortage Staff, Center for Drug Evaluation and Research. “For the past year, the FDA has been working to ensure that supplies of doxorubicin HCl liposome injection were not interrupted.”

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Review Date: 
February 4, 2013