-----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, SDitE01VrcGarcChYqdIVl5cG/1h3nJWwOaiFesHaWsHhnayIE3deK5hv6X9DtfN lRZjVbRiVPAQLGgaxD3hUQ== 0000950130-97-003113.txt : 19970710 0000950130-97-003113.hdr.sgml : 19970710 ACCESSION NUMBER: 0000950130-97-003113 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19970709 ITEM INFORMATION: Other events FILED AS OF DATE: 19970709 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: 97638012 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): July 9, 1997 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) - 2 - Item 5. Other Events ------------ Roberts Pharmaceutical Corporation announced today that it has submitted a Manufacturing Authorization Application (MAA) for European approval of its new drug Agrylin/TM/. The application has been filed with the European Medicines Evaluation Agency (EMEA) in accordance with the centralized procedure for approval of new drugs within the 15-country European Union (EU). Agrylin (anagrelide HC1) is indicated for treating essential thrombocythemia, a life-threatening condition characterized by elevated blood platelet levels. The EU regulatory authorities have accepted Agrylin as a "List B" product, a category given to products considered to represent new drug treatments or important therapeutic advances. Under the European centralized procedure, a successful MAA grants product approval throughout the EU, a market potential for Agrylin that could significantly exceed that of North America. 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 hereunto duly authorized. ROBERTS PHARMACEUTICAL CORPORATION ---------------------------------- (Registrant) Date: July 9, 1997 By: /s/ Anthony A. Rascio --------------------- Anthony A. Rascio Vice President -----END PRIVACY-ENHANCED MESSAGE-----