How the FDA Is Addressing Drug Shortages

If you missed the FDA Webinar on Drug Shortages last Friday, you can Watch a video of the entire presentation, including questions. Download the webinar slides. The webinar, led by Captain Valerie Jensen, R.Ph., Associate Director for the FDA’s Drug Shortage Program, discusses how the FDA responds to drug shortages and what they are doing to…  Read More

Congress Probes Drug Shortages

Drug shortages in the US are a growing crisis, members of Congress were told last Friday, September 23.  And there is no single reason why this is happening and no easy solutions to the problem. Problems lie mostly in older generic versions of sterile injectable drugs, which are low-priced and complicated to manufacture made by a…  Read More

5-FU Added to Drug Shortage List

This morning the FDA added fluorouracil to its drug shortage list. The American Society of Healthcare Pharmacists (ASHP) has also reported a shortage of fluorouracil (5-FU), a common backbone drug for colorectal cancer chemotherapy. Two manufacturers have some doses of the drug on intermittent back order and are shipping it as it becomes available.  A third…  Read More

Leucovorin Shortage Update: Imported Supplies Available

The FDA issued a shortage update for leucovorin on July 21, 2011. While leucovorin remains in shortage from all three US manufacturers, the FDA is temporarily allowing Teva Pharmaceuticals to import calcium folinate solution for injection from Europe. The imported solution is the same strength as  powdered leucovorin calcium for injection once water is added to…  Read More

Avastin Still Approved for Advanced Colorectal Cancer

Yesterday’s recommendation by the FDA’s Oncology Drug Advisory Committee (ODAC) that approval of Avastin for breast cancer be withdrawn will not affect colorectal cancer treatment. Avastin® (bevacizumab) remains on the market in the US and is FDA-approved  for advanced colon and rectal cancer in combination with chemotherapy, both as first-line and second-line therapy. The public hearing…  Read More