UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 November 18, 2004 ----------------- Date of Report (Date of earliest event reported) OSI PHARMACEUTICALS, INC. ------------------------- (Exact name of registrant as specified in its charter) DELAWARE 0-15190 13-3159796 -------- ------- -------------- (State or other jurisdiction of (Commission (I.R.S. Employer incorporation) File Number) Identification No.) 58 SOUTH SERVICE ROAD MELVILLE, NY 11747 ---------------------------- (Address of principal executive offices) (631) 962-2000 ------------------------ (Registrant's telephone number, including area code) N/A -------------------- (Former name or former address, if changed since last report.) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: [ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) [ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a- 12) [ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) [ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) ITEM 8.01 OTHER EVENTS On November 19, 2004, OSI Pharmaceuticals, Inc. (the "Company") issued a press release relating to the Food and Drug Administration's approval of Tarceva(TM) for patients with advanced non-smallcell lung cancer. The Company's press release is attached to this Current Report as Exhibit 99.1 and is incorporated by reference herein. SIGNATURE 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 hereunto duly authorized. Date: November 19, 2004 OSI PHARMACEUTICALS, INC. By: /s/ Robert L. Van Nostrand ------------------------------------- Robert L. Van Nostrand Vice President and Chief Financial Officer (Principal Financial Officer) 3