APP, in conjunction with the FDA, began importing Fresenius Propoven 1% in late 2009 but stopped in Feb. 2010 when the initial supply ran out, according to the letter.
Effective immediate, APP, which is the only company authorized to import Fresenius Propoven 1%, will begin importing the following products:
- DIPRIVAN (20-mL, 50-MI and 100-mL vials)
- APP Propofol 1% (20-mL, 50-MI and 100-mL vials)
- Fresenius Propoven 1% (20-mL, 50-MI and 100-mL vials)
The letter also notes some important difference between U.S.-manufactured propofol and international Fresenius Propoven 1%, including contraindication in patients with peanut and soy allergies. For complete information on the difference, please refer to the APP’s letter.
Read APP’s letter on Fresenius Propoven 1% (pdf).
