Warner Chilcott Announces Receipt of FDA Response to Citizen Petition

Published on Friday, 02 December 2011 08:39 Written by TradersHuddle Staff

DUBLIN, Ireland, Dec. 2, 2011 (GLOBE NEWSWIRE) -- Warner Chilcott plc (Nasdaq:WCRX) 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.

The Company's citizen petition and related information and the FDA's response letter are available on the www.regulations.gov website.

About Warner Chilcott

Warner Chilcott is a leading specialty pharmaceutical company currently focused on the women's healthcare, gastroenterology, dermatology and urology segments of the North American and Western European pharmaceuticals markets. The Company is fully integrated with internal resources dedicated to the development, manufacturing and promotion of its products. WCRX-G

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