FDA OKs first generic version of J&J cancer drug Doxil, says it’ll ease lingering shortage

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WASHINGTON — Federal regulators say approval of the first generic version of cancer drug Doxil will help resolve a lingering shortage triggered by manufacturing deficiencies.

Heather Swift‘s insight:

FDA Approves Generic Cancer Drug To Ease Shortage.

The AP (2/5) reports that the Food and Drug Administration announced Monday that it has approved the first, generic version the cancer treatment, Doxil (doxorubicin hydrochloride liposome injection), which is produced by Sun Pharma Global FZE, a subsidiary of India’s Sun Pharmaceutical Industries Ltd. The agency said the approval would help alleviate an ongoing shortage of Johnson & Johnson’s Doxil, which is "made under contract by Ben Venue Laboratories." J&J says it is seeking a "contract manufacturer to replace Ben Venue."

        According to Reuters (2/5, Clarke), the drug was initially approved in 1995 as a treatment for ovarian cancer; and it is now used to treat multiple myeloma and breast cancer as well as AIDS-related Kaposi’s sarcoma. Sun Pharma Global will be producing the generic version in 20-mg and 50-mg vials. Reuters says the shortages of Doxil began in 2011, after Ben Venue, which is a Boehringer Ingelheim subsidiary, ceased operations, citing quality control and manufacturing problems. Notably, in February 2012, the FDA in an effort to help with the drug shortage, authorized the temporary, controlled importation of a branded version of the drug, called Lipodox, which is also manufactured by Sun Pharma.

        MedPage Today (2/5) adds that Center for Drug Evaluation and Research, Drug Shortage Staff Director, Valerie Jensen, RPh, said, "For the past year, the FDA has been working to ensure that supplies of doxorubicin HCl liposome injection were not interrupted." In addition to the Lipodox import last year, the FDA also "allowed one lot of Doxil manufactured through an unapproved process" by J&J’s Janssen Pharmaceuticals unit.

        Medscape (2/5, Chustecka) says FDA Commissioner Margaret A. Hamburg, MD, explained that the agency "can allow temporary and limited use of a foreign approved drug when there is a critical shortage that cannot be resolved quickly." In its statement Monday, the FDA said it would "continue exercising ‘enforcement discretion’" for the importation of Lipodox, until there is a sufficient amount of Sun Pharma’s generic version available to meet demand.

        Meanwhile, HealthDay (2/5, Preidt) notes that during a speech at the "annual meeting of the American Society for Clinical Oncology last June, Dr. Richard Schilsky, chair of ASCO’s government relations committee, told reporters that some shortages had eased, ‘but there is still an unpredictable availability of many drugs and we are never sure exactly when a generic drug is suddenly going to go out of supply.’" Dr. Schilsky said such shortages cause a "tremendous amount of uncertainty – anxiety for our patients and great difficulty in planning if you’re a physician." In addition to Doxil, other drugs experiencing intermittent shortages include "nitrogen mustard (used to fight blood cancers), paclitaxel (important for breast cancer and other tumors), 5-FU (used in a variety of cancers), and methotrexate (important to treat certain lymphomas)."

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