The Associated Press
June 22, 2010, 4:33PM ET
APP gets FDA approval for version of Cytovene
SCHAUMBURG, Ill.
APP Pharmaceuticals Inc., a unit of Fresenius Kabi Pharmaceuticals Holding Inc., said Tuesday it received Food and Drug Administration for a version of the antiviral medication Cytovene.
Cytovene, or Gancicolvir, is made by Roche. APP said sales in the U.S reached $13.5 million in 2009.
The drug treats Cytomegalovirus retinitis in immunocompromised patients, including patients with AIDS. It is also aimed at preventing Cytomegalovirus disease in at-risk transplant recipients.
Cytomegalovirus retinitis disease can lead to blindness, transplant graft loss and is potentially fatal.
Shares of Fresenius Kabi Pharmaceuticals closed unchanged at 14 cents.
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