US FDA acts on cancer drugs shortages; move applauded by GPhA

The US Food and Drug Administration this week spelt out a series of steps to increase the supply of critically needed cancer drugs and build on President Obama’s Executive Order to help prevent future drug shortages, a situation which has been exacerbated by the temporary closure of Ben Venue Laboratories due to manufacturing issues.

In response to the critical shortage of the cancer drug Doxil (doxorubicin HCl liposome injection), made by Johnson & Johnson, and rapidly declining supplies of methotrexate, the FDA took proactive steps needed to increase available supply for patients in the USA.

For Doxil, there will be temporary importation of a replacement drug, Lipodox (doxorubicin HCl liposome injection), which is expected to end the shortage and fully meet patient needs in the coming weeks. The agency says it has reached a temporary limited agreement to import Indian drugmaker Sun Pharmaceutical's Lipodox.