-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, FG+0bb5cvuOJN+5JoZcrbObzsEA/YxbxYlHJf+Um+W/z9xk9sgaLUpoMWA4PGyfh YLhAW0lWpwcOLF8aVv4+Qw== 0000950130-96-000915.txt : 19960322 0000950130-96-000915.hdr.sgml : 19960322 ACCESSION NUMBER: 0000950130-96-000915 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19960320 ITEM INFORMATION: Other events FILED AS OF DATE: 19960321 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: ROBERTS PHARMACEUTICAL CORP CENTRAL INDEX KEY: 0000853022 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 222429994 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-10432 FILM NUMBER: 96537079 BUSINESS ADDRESS: STREET 1: MERIDIAN CENTRE II STREET 2: 4 INDUSTRIAL WAY W CITY: EATONTOWN STATE: NJ ZIP: 07724 BUSINESS PHONE: 9083891182 MAIL ADDRESS: STREET 1: MERIDIAN CTR II STREET 2: 4 INDUSTRIAL WAY WEST CITY: EATONTOWN STATE: NJ ZIP: 07724 8-K 1 FORM 8-K FORM 8-K SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 20, 1996 ROBERTS PHARMACEUTICAL CORPORATION - -------------------------------------------------------------------------------- (exact name of registrant as specified in its charter) NEW JERSEY 1-1-432 22-2429994 - ------------------- ----------------- ----------------- (State or other (Commission (IRS Employer jurisdiction of File Number) Identification incorporation) Number) Meridian Center II 4 Industrial Way West Eatontown, New Jersey 07724 - -------------------------------------------------------------------------------- (Address of principal executive offices, including zip code) Registrant's telephone number, including area code: 908-389-1182 Meridian Center II 4 Industrial Way West Eatontown, New Jersey 07724 - -------------------------------------------------------------------------------- (Former name or former address, if changed from last report) Item: 5. Other Events ------------ Roberts Pharmaceutical Corporation announced that it has received notice from the Food and Drug Administration (FDA) that the Company's New Drug Application (NDA) for AGRELIN (anagrelide) has been officially accepted for filing, effective January 29, 1996. According to regulations, unless extended for administrative reasons, the FDA is now obliged to complete the NDA review and determine the approvability of AGRELIN within 180 days from the date of filing. Roberts received notification of the NDA filing status of AGRELIN earlier this month. AGRELIN is an anti-platelet drug used to treat "thrombocytosis", a blood disorder characterized by high blood platelet counts and an abnormally high incidence of adverse blood clotting events including heart attack and stroke. Thrombocytosis can occur spontaneously without any known cause or can be caused by certain leukemias and other bone marrow tumors. Published studies confirm that AGRELIN reduces the morbidity and mortality of heart attack and stroke in thrombocytosis patients. AGRELIN is currently supplied both internationally and in the US by Roberts under a compassionate IND. SIGNATURES Pursuants 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. ROBERTS PHARMACEUTICAL CORPORATION ---------------------------------- (Registrant) Date: March 21, 1996 By: /s/ Anthony A. Rascio ------------------------------- Anthony A. Rascio Vice President -----END PRIVACY-ENHANCED MESSAGE-----