-----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, Q/wiJ9s+MbSQa6LmQm4LoJh95i4FyjNgmLNKQfiwRJIO0AuZVdBY2wl6RbZK0MxJ TpWu0LfW4aoL5dXyWmX3ZQ== 0000950130-96-001099.txt : 19960402 0000950130-96-001099.hdr.sgml : 19960402 ACCESSION NUMBER: 0000950130-96-001099 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19960326 ITEM INFORMATION: Other events FILED AS OF DATE: 19960401 SROS: NONE 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: 96542533 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 26, 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) -2- Item 5. Other Events ------------ Roberts Pharmaceutical Corporation announced that the Food and Drug Administration (FDA) has requested additional information regarding the Company's New Drug Application for ProAmatine(TM) (midodrine). The FDA notes that while midodrine has a clear pressor effect in both the supine and standing position, further data are needed before the drug can be approvable for orthostatic hypotension (a low blood pressure condition). The Company is reviewing the details of the FDA's request and how to satisfy the apparent deficiency. To date, the FDA has not approved any drug for orthostatic hypotension. A definitive clinical methodology for testing a drug for this indication has never been established by the FDA. 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: April 1, 1996 By: /s/ Anthony A. Rascio ----------------------------- Anthony A. Rascio Vice President -----END PRIVACY-ENHANCED MESSAGE-----