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FDA Actions to Increase Supply of Critical Cancer Drugs in Shortage
In response to the shortage of cancer drug Doxil® (doxorubicin hydrochloride liposome injection) and rapidly declining supplies of methotrexate, FDA has taken steps that will increase the available supply of these lifesaving medications to United States patients. For Doxil, there will be temporary importation of a replacement drug, Lipodox (doxorubicin hydrochloride liposome injection), which is expected to end the shortage and fully meet patient needs in the coming weeks, as explained in an FDA news release. FDA’s exercise of enforcement discretion for Lipodox is a temporary, limited arrangement specific to Sun Pharma Global FZE and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd. For methotrexate, FDA has successfully engaged many firms to assist in maintaining supplies. The agency also prioritized the review of, and subsequently approved, a preservative-free methotrexate generic drug manufactured by APP Pharmaceuticals. These actions are expected to further bolster the supply of methotrexate and help avert a shortage of this lifesaving medication. In addition, in response to President Obama’s October 31, 2011, Executive Order on prescription drug shortages, FDA has released a draft guidance (PDF) for industry on detailed requirements for mandatory and voluntary notifications to FDA of drug discontinuances or issues that may lead to a drug shortage or supply disruption.
