FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the month of February, 2003
Commission File Number 333-12634
_________GALEN HOLDINGS PUBLIC LIMITED COMPANY______ |
Seago Industrial Estate Craigavon BT63 5UA United Kingdom (Address of principal executive offices) |
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F X Form 40-F.........
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ..... No ..X...
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- ________
SCHEDULE OF INFORMATION CONTAINED IN THIS REPORT
Notification to the London Stock Exchange and the Irish Stock Exchange concerning the press release made by Galen Holdings PLC on 5 February 2003 announcing that it received an approvable letter for its new Ovcon product.
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
GALEN HOLDINGS PUBLIC LIMITED COMPANY | |
Date: February 7, 2003 | By: /s/ Anthony D. Bruno____________ Name: Anthony D. Bruno Title: Senior Vice President, Corporate Development and General Counsel |
<PRESS RELEASE>
GALEN HOLDINGS PLC
RECEIVES APPROVABLE LETTER FOR NEW OVCON
Craigavon, Northern Ireland, UK / Rockaway, New Jersey, US... 5 February 2003...Galen Holdings PLC (LSE: GAL, Nasdaq: GALN), the international pharmaceutical company, announced today that it has received an approvable letter for its new Ovcon (R) product, an oral contraceptive, from the US Food and Drug Administration (FDA). The FDA accepted the New Drug Application for filing in June 2002. An approvable letter represents an important step before a product receives FDA approval for marketing in the United States.
The items arising from the FDA's letter include confirmation of the resolution of certain issues at the facility where the product is manufactured, and final agreement with the agency on product labelling and expiration dating. Galen expects that these items will be addressed and a response submitted to the agency as rapidly as possible.
Commenting on the announcement, Roger Boissonneault, Galen's Chief Executive, said:
"We are pleased that we have reached this milestone for our new product on schedule. We are committed to expeditiously fulfilling the remaining requirements of the FDA and progressing towards approval."
Galen is an international pharmaceutical company based in Craigavon, Northern Ireland and Rockaway, New Jersey, US. Galen develops, acquires and manufactures branded prescription pharmaceutical products, which are promoted by the Company's sales and marketing organisations in the UK, Ireland and the US.
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Enquiries:
Galen Holdings PLC
David Kelly, Sr. Vice President, Finance and Planning.
+44 (0) 283 833 4974
Today: Rockaway NJ. + 1 973 442 3327
Financial Dynamics
Sophie Pender-Cudlip/ Francetta Carr
+ 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.
