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 www.fda.gov/Drugs/DrugSafety/DrugShortages 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 appmedicalinfo@APPpharma.com.