Blog | Wednesday, February 22, 2012

QD: News Every Day--FDA announces two new suppliers for scare cancer drugs

The U.S. Food and Drug Administration will import one cancer drug and has approved a new manufacturer for another one to respond to serious shortages.

The cancer drug Doxil will temporarily be replaced by Lipodox (doxorubicin hydrochloride liposome injection), which is expected to end the shortage and fully meet patient needs in the coming weeks, the agency said in a press release.

Doxil is used to treat ovarian cancer after failure of platinum-based chemotherapy, and for AIDS-related Kaposi's sarcoma and multiple myeloma. FDA anticipates that the incoming supply of Lipodox will fully meet demand. The import is a temporary, limited arrangement specific to the drug's manufacturer and distributor.

And, FDA offered expedited review to a preservative-free methotrexate used for intrathecal treatment of children with acute lymphocytic leukemia and for the high-dose therapy of osteosarcoma. The generic drug is made by APP Pharmaceuticals. It will become available in March and continue indefinitely. Second, drug-maker Hospira released 31,000 vials of new product, enough for more than one month's worth of demand. Other drug makers increasing production are Mylan and Sandoz Pharmaceuticals.

"A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration," said FDA Commissioner Margaret A. Hamburg, MD, FACP. "Through the collaborative work of FDA, industry, and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need."

The agency's website offers more on the wide range of drug shortages that are occurring across the U.S.