Agency Admits Mistake
FDA Ends Orphan Exclusivity For Octapharma Drug Wilate
By Mari Serebrov
Friday, August 10, 2012
In an agency first, the FDA is rescinding an orphan drug exclusivity, saying it made a mistake two years ago in determining that Octapharma USA Inc.'s Wilate was superior to CSL Behring LLC's previously approved Humate-P.
Outside of the US
Part of Thomson Reuters
Note: our contact information has changed
In the U.S. and Canada: +1-800-336-4474
Outside the U.S.: +44-203-684-1796
Hours: Monday - Friday, 8:00am - 6:00 pm EST
© 2017 Thomson Reuters. Reproduction, reposting content is strictly prohibited.