The United States today said that it will import cancer drug manufactured in India to overcome the acute shortage of the medicine used in the treatment of ovarian, bone marrow and AIDS-related skin cancer.
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 the 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 the patients’ needs. FDA said that 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 authorised 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 the FDA Commissioner, Dr Margaret Hamburg.