(Page 3 of 3)

APP’s application for preservative-free methotrexate is a supplement to its already approved generic drug application that the firm had previously discontinued. When FDA became aware of potential problems with the supply of the drug (due to the largest manufacturer, Bedford/Ben Venue voluntarily closing its plant), the Agency reached out to other firms to see how FDA could assist to meet the shortfall. 
 
Prior to approval of APP’s application and subsequent to Ben Venue’s voluntary shutdown, FDA worked with Ben Venue on release of already manufactured preservative-free methotrexate, following confirmation of its safety. This supply is available already and will provide emergency supplies as the other firms also work to increase production of methotrexate in response to requests by FDA and the public.
 
The Administration also announced on October 31, 2011, its support for bipartisan legislation  that would require all prescription drug shortages to be reported to FDA and would give FDA new authority to enforce these requirements. While additional manufacturing capacity is necessary to fully address the drug shortage problem, additional early notification to FDA can have a significant, positive impact on addressing the incidence and duration of drug shortages.
 
For more information:

Drug Shortages
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm

Drug Shortage Guidance
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation

 

---

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

1

2

3

---

Printable Version