May 15, 2010


 FDA allows propofol imports to address short supply

Posted May 1, 2010

The Food and Drug Administration is temporarily allowing APP Pharmaceuticals to import an unapproved propofol 1 percent product to help address a shortage of the anesthetic agent.

APP previously received FDA approval, late last year, to import and distribute Fresenius Propoven 1% after recalls of propofol injection by other U.S. manufacturers—Hospira and Teva Animal Health. The FDA reinstated permission for APP to import Fresenius Propoven 1% following continuing supply issues with other U.S. manufacturers.

APP's parent company, Fresenius Kabi of Germany, manufactures Fresenius Propoven 1% in FDA-compliant facilities.

APP, with FDA agreement, is temporarily introducing Fresenius Propoven 1% in a 20-mL glass ampule. Health care providers should use a 5 micron filter when withdrawing the product from the glass ampule. APP is shipping a Becton Dickinson 5 micron blunt filter needle with each 20-mL glass ampule of Fresenius Propoven 1%.

Fresenius Propoven 1% is also available in 20-mL, 50-mL, and 100-mL vials. APP will continue to offer its own brand-name propofol 1% product, Diprivan, and increase the supply of its generic product.

Additional information and a Q&A about the propofol shortage and Fresenius Propoven 1% are available from the FDA at by clicking on "Current Drug Shortages" and scrolling down to the propofol entry.

Health care providers may contact APP Customer Service by calling (888) 386-1300 or contact APP Medical Information by calling (800) 551-7176 or e-mailing