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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 20, 1996
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 that it has received
notice from the Food and Drug Administration (FDA) that the Company's New Drug
Application (NDA) for AGRELIN (anagrelide) has been officially accepted for
filing, effective January 29, 1996.
According to regulations, unless extended for administrative reasons,
the FDA is now obliged to complete the NDA review and determine the
approvability of AGRELIN within 180 days from the date of filing. Roberts
received notification of the NDA filing status of AGRELIN earlier this month.
AGRELIN is an anti-platelet drug used to treat "thrombocytosis", a
blood disorder characterized by high blood platelet counts and an abnormally
high incidence of adverse blood clotting events including heart attack and
stroke. Thrombocytosis can occur spontaneously without any known cause or can
be caused by certain leukemias and other bone marrow tumors. Published studies
confirm that AGRELIN reduces the morbidity and mortality of heart attack and
stroke in thrombocytosis patients.
AGRELIN is currently supplied both internationally and in the US by
Roberts under a compassionate IND.
SIGNATURES
Pursuants 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 21, 1996 By: /s/ Anthony A. Rascio
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Anthony A. Rascio
Vice President
