RNS Number:1238S
Galen Holdings PLC
17 November 2003



                           GALEN HOLDINGS PLC

                  NEW OVCON(R) 35 RECEIVES FDA APPROVAL



Craigavon, Northern Ireland, UK /Rockaway, New Jersey, US, 17 November 2003 -
Galen Holdings PLC (LSE: GAL, Nasdaq: GALN), the specialty pharmaceutical
company, today announced the U.S. Food and Drug Administration (FDA) approval of
Ovcon(R) 35 (norethindrone and ethinyl estradiol tablets, chewable).



Ovcon(R) 35 chewable tablets are a convenient form of Galen's successful Ovcon
(R) 35 oral contraceptive containing 0.4mg  norethindrone and 35mcg ethinyl
estradiol.  Ovcon(R) 35 is marketed in the United States by Warner Chilcott,
Galen's US subsidiary. The new product  gives the option to chew or swallow and
has a pleasant  flavour. It is designed to enhance both convenience and
compliance for patients taking oral contraceptives.

Galen filed a New Drug Application (NDA) for the product on 29 March 2002 and
received an Approvable Letter from the Agency on 31 January 2003.  This final
approval signals that the outstanding issues addressed in that letter have now
been resolved to the satisfaction of the Agency.



 Commenting on the approval, Roger Boissonneault, Chief Executive Officer of
Galen said;  "The approval of this second generation product will enable us to
continue to develop our Ovcon(R) franchise, which has grown by almost 30% in the
last year. This new product will help to improve patient compliance, while at
the same time enhancing convenience."



Note: This product (like all oral contraceptives) is intended to prevent
pregnancy.  It does not protect against HIV infection (AIDS) and other sexually
transmitted diseases.  Cigarette smoking increases the risk of serious adverse
effects on the heart and blood vessels from oral contraceptive use.  This risk
increases with age and with the amount of smoking (15 or more cigarettes per day
has been associated with a significantly increased risk) and is quite marked in
women over 35 years of age.  Women who use oral contraceptives should not smoke.



                                   #   #   #

Contacts:


Galen Holdings PLC
David Kelly, Sr. Vice President, Finance and Planning:  Tel:44 (0) 283 833 4974



Financial enquiries:
Financial Dynamics
Andrew Dowler/Francetta Carr                            Tel:44 (0) 207 831 3113



For further information on Galen, please visit www.galenplc.com





Note:



Forward looking statements in this report, including, without limitation,
statements relating to Galen'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
Galen 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:  Galen'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 Galen 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
Galen with the SEC.  Galen 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
END

REABRBFTMMJBMPJ