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U.S. Department of Health and Human Services

Drugs

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Doxorubicin hydrochloride liposome injection

Today, FDA announces major actions taken to bolster the supply of Doxil (Janssen Research & Development LLC.) and preservative-free formulations of methotrexate.

Liposomal doxorubicin
In response to the critical shortage of Doxil (doxorubicin hydrochloride liposome injection), effective immediately the U.S. Food and Drug Administration is exercising its enforcement discretion for the temporary importation and distribution of Sun Pharma Global's Lipodox (doxorubicin hydrochloride liposome injection) in the United States by Sun Pharma Global FZE and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd. 

FDA’s exercising of regulatory discretion during this critical shortage of Doxil is not expected to eliminate the shortage immediately, but will begin the process of addressing U.S. patient needs. Doxil has been in short supply for several months due to manufacturing issues at an Ohio manufacturing facility. This facility voluntarily closed on November 19, 2011. FDA continues to work with Janssen Research & Development LLC. (the distributor) and Ben Venue Laboratories, Inc. (Janssen’s contract manufacturer) to address the short supply.

Temporary importation of foreign drugs is considered in rare cases when a shortage of an approved critical US drug exists and the shortage cannot be resolved by manufacturers of the approved drug in the immediate future. When a firm is located that is willing and able to import a foreign drug, FDA evaluates the overseas drug to ensure that it is of adequate quality and that the drug does not pose significant risks for US patients. FDA exercises its enforcement discretion for temporary importation of an overseas drug into the US market when these conditions are met. 

FDA's exercise of enforcement discretion for the importation and distribution of Sun Pharma Global's Lipodox (Doxorubicin Hydrochloride Liposome Injection) is limited to Sun Pharma Global FZE and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd. Importation or distribution of this drug in the United States by any other entity is outside the scope of the discretion being exercised, Sun Pharma Global's Lipodox (Doxorubicin Hydrochloride Liposome Injection) remains unapproved by FDA for marketing in the US.

Doxil is indicated for the treatment of ovarian cancer with disease progression after platinum-based chemotherapy, AIDS-related Kaposi’s sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy and multiple myeloma, in combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy.

Information about the imported drug, and how patients can access supplies, is posted on the FDA Drug Shortage website at http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm, along with the Dear Healthcare Professional letter from the company that is importing the drug.

Preservative-free methotrexate
FDA has completed a prioritized review of, and approved, a preservative-free methotrexate generic drug manufactured by APP Pharmaceuticals. APP’s application for preservative-free methotrexate is a supplement to its already approved generic drug. Following the approval of APP’s supplement for methotrexate, FDA expects that product to become available in March and continue indefinitely.

The supplies of the preservative-free formulation of methotrexate have been rapidly declining due to manufacturing issues at an Ohio manufacturing facility. This facility voluntarily closed on November 19, 2011. Prior to approval of APP’s application and since the Ohio firm’s shutdown, FDA worked with the Ohio firm on release of already manufactured preservative-free methotrexate, following confirmation of its safety. This supply is currently available for emergency supplies, pending distribution of APP’s methotrexate and as the other firms also work to increase production of methotrexate in response to requests by FDA and the public.

Preservative-free methotrexate administered by intrathecal injection is indicated for prevention and treatment of meningeal leukemia. Preservative-free methotrexate, administered by intravenous infusion, is also indicated as high-dose therapy for the treatment of osteosarcoma. In addition, preservative-free methotrexate should be used in neonates who require methotrexate therapy.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).