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Drug & Device News

By ALM Staff | Law Journal Newsletters |
March 29, 2012

To Address Shortages, FDA Allows Import of Unapproved Cancer Drugs

Responding to concerns that supplies of certain cancer treatment drugs had become dangerously short, the U.S. Food and Drug Administration (FDA) took steps in February to address the crisis; the agency temporarily authorized the import of two unapproved medications. The FDA announced it would allow the importation of the drug Lipodox (doxorubicin hydrochloride liposome injection), manufactured by India's Sun Pharma Global, to replace Doxil (doxorubicin hydrochloride liposome injection). Doxil, which is commonly used to treat certain ovarian cancer patients and patients with AIDS-related Kaposi's sarcoma or multiple myeloma, became scarce after the drug's manufacturer shut down production at its Ohio facility late last year. The FDA, which in rare emergency circumstances allows the importation of unapproved drugs that are critical to patients, expects the Lipodox imports to meet all U.S. patient needs.

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