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Home » FDA Agrees to Block Asacol ANDAs, Grants Warner Chilcott’s Petition
FDA Agrees to Block Asacol ANDAs, Grants Warner Chilcott’s Petition
December 6, 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 do not meet bioequivalence standards using in vitro dissolution and comparative pharmacokinetic (PK) data.