Warner Chilcott Announces FDA Acceptance of NDA Submission for Low Dose Oral Contraceptive

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Wed May 27, 2009 2:00pm EDT

Warner Chilcott Announces FDA Acceptance of NDA Submission for Low Dose Oral
Contraceptive

ARDEE, Ireland, May 27 /PRNewswire-FirstCall/ -- Warner Chilcott Limited
(Nasdaq: WCRX) announced today that the U.S. Food and Drug Administration
(FDA) has filed for standard review the new drug application (NDA) for WC
3016, a low dose oral contraceptive.  The NDA for WC 3016 was submitted by its
subsidiary, Warner Chilcott Company, LLC, on March 26, 2009.


About Warner Chilcott
Warner Chilcott is a leading specialty pharmaceutical company currently
focused on the women's healthcare and dermatology segments of the U.S.
pharmaceuticals market. The Company is a fully integrated company with
internal resources dedicated to the development, manufacturing and promotion
of its products. WCRX-G 

Read more on http://www.wcrx.com. 

Warner Chilcott's Forward Looking Statements: 
This press release contains forward-looking statements, including statements
concerning our operations, our anticipated 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 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. 

The following represent some, but not necessarily all, of the factors that
could cause actual results to differ from historical results or those
anticipated or predicted by our forward-looking statements: our substantial
indebtedness; competitive factors in the industry in which we operate
(including the approval and introduction of generic or branded products that
compete with our products); our ability to protect our intellectual property;
a delay in qualifying our manufacturing facility to produce our products or
production or regulatory problems with either third party manufacturers upon
whom we may rely for some of our products or our own manufacturing facilities;
pricing pressures from reimbursement policies of private managed care
organizations and other third party payors, government sponsored health
systems, the continued consolidation of the distribution network through which
we sell our products, including wholesale drug distributors and the growth of
large retail drug store chains; the loss of key senior management or
scientific staff; adverse outcomes in our outstanding litigation or an
increase in the number of litigation matters to which we are subject;
government regulation affecting the development, manufacture, marketing and
sale of pharmaceutical products, including our ability and the ability of
companies with whom we do business to obtain necessary regulatory approvals;
our ability to manage the growth of our business by successfully identifying,
developing, acquiring or licensing new products at favorable prices and
marketing such new products; our ability to obtain regulatory approval and
customer acceptance of new products, and continued customer acceptance of our
existing products; changes in tax laws or interpretations that could increase
our consolidated tax liabilities; the other risks identified in our Annual
Report on Form 10-K for the year ended December 31, 2008; and other risks
detailed from time-to-time in our public filings, financial statements and
other investor communications.

We caution you that the foregoing list of important factors is not exclusive.
In addition, in light of these risks and uncertainties, the matters referred
to in our forward-looking statements may not occur. 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. 


SOURCE  Warner Chilcott Limited

Rochelle Fuhrmann, Investor Relations, +1-973-442-3281, rfuhrmann@wcrx.com
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