ARDEE, Ireland, July 16 /PRNewswire-FirstCall/ — Warner Chilcott plc (Nasdaq: WCRX) announced today that it has received a
communication from the U.S. Food & Drug Administration (FDA)
related to its next generation Actonel® product (risedronate
sodium) delayed-release tablets extending the Prescription Drug
User Fee Act (PDUFA) date by three months to allow sufficient time
to review additional information solicited by the FDA and
previously provided by the Company. The new PDUFA date is
October 24, 2010.
The Company
Warner Chilcott is a leading
specialty pharmaceutical company currently focused on the
gastroenterology, women’s healthcare, dermatology and urology
segments of the North American and Western European pharmaceuticals
markets. The Company is a fully integrated company 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,
including statements concerning our operations, our economic
performance and financial condition, and our business plans and
growth strategy and product development efforts. 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 ar
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