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
Forward Looking Statements
This press release contains forward-looking statements. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "may," "might," "will," "should," "estimate," "project," "plan," "anticipate," "expect," "intend," "outlook," "believe" and other similar expressions are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as may be required by law.