The Link isn't Posting, for some reason. But, anyway, if you do a Google news search for APP Pharmaceuticals, about the 4th or 5th one down is an article from Javma News, which states...
FDA Allows Propofol Imports to Address Short Supply
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.
I think this is going to have SOME kind of positive impact on their adjusted EBITDA, along with the approval of the other two drugs being marketed and sold in the U.S.
But will they be able to make north of $177 mln a qtr for the next 3 qtrs., is still the question?
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