-----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, UmXWeuIecsHweg7jQMYfG6j4AsyVyDDjW9Sk+u0ZymXSFlRY9KqOul7+4hfIqXcQ sXT0WXmcvasmmMDBuPg1XA== 0000950130-96-002097.txt : 19960605 0000950130-96-002097.hdr.sgml : 19960605 ACCESSION NUMBER: 0000950130-96-002097 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19960531 ITEM INFORMATION: Other events FILED AS OF DATE: 19960604 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: 96576418 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): May 31, 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 been informed that the Food and Drug Administration (FDA) will shortly issue an "approvable letter" for ProAmatine (TM) (midodrine) pursuant to Subpart H regulations for "Accelerated Approval of New Drugs For Serious Or Life-Threatening Illnesses". PromAmatine would be the first cardiovascular drug to be approved by the FDA under the accelerated process. ProAmatine, which the FDA has designated as an "orphan drug", has been developed by Roberts to fill the U.S. therapeutic void in the treatment of orthostatic hypotension. A meeting of the Company and FDA took place on May 22, 1996 to discuss accelerated approval of ProAmatine. The FDA has now agreed that, under the accelerated process, ProAmatine is eligible for approval based on a surrogate endpoint for orthostatic hypotension, i.e., the drug's clinically demonstrated ability to increase blood pressure. In turn, Roberts has agreed to perform post-marketing Phase IV studies to satisfy the FDA's request for additional studies to verify clinical benefit. Roberts and FDA will meet again to discuss the final design of the Phase IV protocols. Meanwhile, Roberts will initiate pre-launch activities, including the preparation of its U.S. sales force in anticipation of FDA clearance of the 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 hereunto duly authorized. ROBERTS PHARMACEUTICAL CORPORATION ------------------------------------ (Registrant) Date: June 4, 1996 By:/s/ Anthony A. Rascio -------------------------------------- Anthony A. Rascio Vice President -----END PRIVACY-ENHANCED MESSAGE-----