-----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, EjImRtDcqSE9Z+ZlDKgZIBzZp2quMgoqqZ05miVM+IkFE/mflREqtJXprxuzIfZF hpZjtKNRTp50LSRwPX7skw== 0000950130-96-003526.txt : 19960912 0000950130-96-003526.hdr.sgml : 19960912 ACCESSION NUMBER: 0000950130-96-003526 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19960909 ITEM INFORMATION: Other events FILED AS OF DATE: 19960911 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: 96628538 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): September 9, 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 cleared ProAmatine/TM/ (midodrine hydrochloride) for U.S. marketing. The Company anticipates the U.S. launch of ProAmatine shortly. In an earlier press release, the Company announced receipt of an FDA approval letter noting that "ProAmatine is approvable under 21 CFR Subpart H -- Accelerated approval on new drugs for serious or life-threatening illnesses". Roberts further noted that ProAmatine, which had been developed to fill the U.S. therapeutic void in the treatment of orthostatic hypotension (a low blood pressure condition), was approvable based on a surrogate endpoint, i.e., standing blood pressure. As required by regulations, Roberts then submitted labeling and promotional material to FDA for review as a prerequisite to marketing. That step of the review process has now been completed and Roberts is preparing for the near-term launch of ProAmatine. The Company also noted that ProAmatine is not only the first cardiovascular drug cleared for marketing under the accelerated process, it is also the first of Roberts, pipeline drugs to be approved for sale in the U.S. market. 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: September 11, 1996 By: /s/ Anthony A. Rascio ----------------------------------- Anthony A. Rascio Vice President -----END PRIVACY-ENHANCED MESSAGE-----