Warner Chilcott, PLC Announces Receipt of FDA Response to Citizen Petition
Published: Dec 02, 2011
DUBLIN, Ireland, Dec. 2, 2011 (GLOBE NEWSWIRE) -- Warner Chilcott plc (Nasdaq:WCRX - News) today announced that it has received the Food and Drug Administration's ("FDA's") response to a citizen petition that it filed regarding its ASACOL and ASACOL HD products. In its petition, Warner Chilcott requested that the FDA confirm that it will require applicants submitting abbreviated new drug applications ("ANDAs") for generic versions of the Company's ASACOL or ASACOL HD products to satisfy the bioequivalence requirements applicable to ANDAs previously articulated by the FDA in August 2010. The FDA stated that it "continues to agree with the reasoning and conclusions contained in [its] August 2010 Petition response" and granted the Company's citizen petition.