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Warner Chilcott PLC (WCRX)

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Monday 23 August, 2004

Warner Chilcott PLC

Regulatory Approval

Warner Chilcott PLC
23 August 2004


Craigavon, Northern Ireland/Rockaway, NJ                          23 August 2004


                                Warner Chilcott PLC

                        Announces approval of FemtraceTM



Craigavon, Northern Ireland/Rockaway, New Jersey, USA - 23 August 2004: Warner
Chilcott PLC ('Warner Chilcott') (LSE: WCRX, Nasdaq: WCRX), announced today that
the US Food & Drug Administration (FDA) has approved FemtraceTM tablets for the
relief of the vasomotor symptoms of menopause.  An approval was not granted for
the secondary indication of vulvar-vaginal atrophy. The New Drug Application
(NDA) for FemtraceTM was accepted for filing on December 19, 2003.  All dosage
strengths, i.e. 0.45 mg, 0.9 mg and 1.8 mg of estradiol acetate were approved.
The Company expects to launch FemtraceTM in the first quarter of 2005.



FemtraceTM is the first approval of three applications currently filed with the
FDA.  Approvals for femhrt(R)Lo, a low-dose version of femhrt(R), a combined
oral estrogen-progestogen product, and a line extension to Doryx(R), a
tetracycline antibiotic for the treatment of acne, are expected in the first
half of next year.



Warner Chilcott also confirms today that, following recent meetings with LEO
Pharma S/A (LEO), it is expected that an NDA for Dovobet(R), a combination of
calcipotriene and betamethasone dipropionate, will be filed by March 2005.
Dovobet(R) is indicated for the treatment of psoriasis.  Under the terms of a
Master Agreement dated April 1, 2003, Warner Chilcott has agreed to license
Dovobet(R) from LEO upon marketing approval of the product for the US market.
Dovobet(R) has been approved and is currently marketed in at least 23 countries
worldwide.



The Company has decided to discontinue its programmes to develop a metronidazole
vaginal ring to treat bacterial vaginosis and a fluconazole vaginal ring for
candidiasis.



Commenting on today's news, Roger Boissonneault, CEO of Warner Chilcott, said:



'We welcome the approval of FemtraceTM.  This is the first of a series of new
products either currently filed with the FDA or due to be submitted in 2005.
These products will help strengthen our presence in women's healthcare and
dermatology and will drive future growth of Warner Chilcott past the end of this
decade.  My congratulations go to all those colleagues who contributed to this
important project.'



                                    - END -





For further information, please contact:




Warner Chilcott PLC
David G. Kelly                              Tel:     + 44 (0) 28 3836 3634

Financial Dynamics
Sophie Pender-Cudlip/Lucy Briggs            Tel:     + 44 (0) 20 7831 3113





For further information on Warner Chilcott visit: www.warnerchilcott.com





Note:



Forward looking statements in this report, including, without limitation,
statements relating to Warner Chilcott's plans, strategies, objectives,
expectations, intentions and adequacy of resources, are made pursuant to the
safe harbor provisions of the U.S. Private Securities Litigation Reform Act of
1995.  These forward looking statements involve known and unknown risks,
uncertainties and other factors that may cause the actual results, performance
or achievements of Warner Chilcott to be materially different from any future
results, performance or achievements expressed or implied by such forward
looking statements.  These factors include, among others, the following: Warner
Chilcott's ability to manage its growth, government regulation affecting the
development, manufacture, marketing and sale of pharmaceutical products,
customer acceptance of new products, competitive factors in the industries in
which Warner Chilcott operates, the loss of key senior management or scientific
staff, exchange rate fluctuations, general economic and business conditions, and
other factors described in filings of Warner Chilcott  with the SEC.  Warner
Chilcott undertakes no obligation to publicly update or revise any forward
looking statement, whether as a result of new information, future events or
otherwise.






                      This information is provided by RNS
            The company news service from the London Stock Exchange