View Single Post
Old 02-19-2010, 10:40 PM   #1
News
Senior Member
 
News's Avatar
 
Join Date: Oct 2007
Posts: 20,103
Amgen's Prolia Complete Response submission: FDA classifies and sets PDUFA date

Amgen Inc. today announced that the U.S. Food and Drug Administration (FDA) has evaluated the content of the Company's Complete Response submission for Proliaâ„¢ (denosumab) in the treatment of postmenopausal osteoporosis and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act (PDUFA) action date of July 25, 2010.

More...
News is offline   Reply With Quote