Generic Version Of Cancer Drug Doxil Approved By FDA

Editor's Choice
Main Category: Ovarian Cancer
Also Included In: Cancer / Oncology;  Regulatory Affairs / Drug Approvals
Article Date: 06 Feb 2013 - 6:00 PST


The U.S. Food and Drug Administration has just approved a generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection).

There is currently a serious shortage of the drug Doxil, and the decision by the FDA to allow a generic version on the market will help the thousands of people in need of the drug to survive.

The generic version of Doxil is developed by Sun Pharma Global FZE, a subsidiary of India's Sun Pharmaceutical Industries Ltd. Doxil, which is made by Johnson and Johnson. The medication is used to treat Ovarian cancer as well as multiple myeloma.

The drug is currently on the FDA's shortage list, and the FDA is using a review system to speed up the review of generic medications. An executive order in 2011 by President Obama made generic versions of drugs a priority.

Capt. Valerie Jensen, R.Ph., director, Drug Shortage Staff, Center for Drug Evaluation and Research, FDA, said:

"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. For the past year, the FDA has been working to ensure that supplies of doxorubicin HCl liposome injection were not interrupted."

Generic versions of drugs that are approved by the FDA are of the same quality and strength as the brand name versions; they must pass the same quality standards and tests.

Sun Pharma Global FZE (Sun) developed the generic version of Doxil. A doxorubicin hydrochloride liposome injection available in 20-milligram and 50-milligram vials will be available to be administered intravenously by a health care professional.

FDA working to meet the demand of the drug

In order to meet the demand of the doxorubicin hydrochloride liposome injection - which can't be met due to the Doxil shortage - the FDA recently allowed the importation of a drug with the same active ingredient, called Lipodox. The drug is produced by Sun and distributed by Caraco Pharmaceutical Laboratories. However, it is not approved in the U.S.

The FDA concluded:

"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."

(Generic) Doxorubicin HCl Liposome Injection USP, 2mg/mL, packaged in 20 mg/10mL and 50 mg/25mL single-use vials, is therapeutically equivalent to (brand name) Doxil Liposome Injection, 2 mg/mL of Janssen Research and Development, LLC (part of Johnson & Johnson).

Written by Joseph Nordqvist


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