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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 6, 1997
ROBERTS PHARMACEUTICAL CORPORATION
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(exact name of registrant as specified in its charter)
New Jersey 1-1-432 22-2429994
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(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification
incorporation) Number)
Meridian Center II
4 Industrial Way West
Eatontown, New Jersey 07724
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(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
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(Former name or former address, if changed from last report)
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Item 5. Other Events
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Roberts Pharmaceutical Corporation announced today that its new drug
AGRYLIN(TM) has been given "Priority Review" status by the Health Protection
Branch, Canada (HPB).
Roberts filed a New Drug Submission for AGRYLIN with the Canadian
regulatory agency subsequent to recent FDA notification that the product was
approvable in the U.S. for treating thrombocythemia. This is a life-threatening
condition characterized by elevated blood platelet levels.
Roberts also plans to file a Product License Application this year for
AGRYLIN according to the EMEA harmonization procedures for approval of new drugs
within the European Community. Filings in other geographic locations are being
pursued.
The Company noted that AGRYLIN is the second product to emerge from its
pipeline, but the first of its proprietary products for which the Company has
worldwide marketing rights.
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
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(Registrant)
Date: March 11, 1997 By: /s/ Anthony A. Rascio
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Anthony A. Rascio
Vice President
