USA to import cancer drug from India
Exercising its enforcement discretion, the Federal Drug Administration (FDA) said the chemotherapeutic drug Lipodox will be imported as an alternative to Doxil. Doxil, it said, is used in multiple treatment regimens, including treatment of ovarian cancer after failure of platinum-based chemotherapy. The drug is also indicated for use in AIDS-related Kaposi`s sarcoma and multiple myeloma.
FDA anticipates that the incoming supply of Lipodox will be able to fully meet patient needs. FDA said it has entered into an agreement with Sun Pharma Global FZE, which manufactures the drug at the FDA-inspected facility in Halol, Gujarat.
FDA said its 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.
"A drug shortage can be a frightening prospect for patients and President (Barack) Obama made it clear that preventing these shortages from happening is a top priority of his administration," said FDA Commissioner Margaret Hamburg.
In addition, in response to the President Executive Order on prescription drug shortages, FDA also issued draft guidance to industry on detailed requirements for both mandatory and voluntary notifications to the agency of issues that could result in a drug shortage or supply disruption.