FDAnews Drug Daily Bulletin

FDA Agrees to Block Asacol ANDAs, Grants Warner Chilcott’s Petition

Dec. 13, 2011
The FDA has granted a Warner Chilcott citizen petition, agreeing not to approve generic versions of the company’s ulcerative colitis drug Asacol that fail to meet bioequivalence standards using in vitro dissolution and comparative pharmacokinetic (PK) data.
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