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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):
February 3, 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)
Meridan 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 it has
received notification from the Food and Drug Administration (FDA) that the
Company's New Drug Application for AGRYLIN (TM) is approvable.
AGRYLIN (anagrelide hydrochloride) has been developed by Roberts for the
treatment of essential thrombocythemia, a life threatening condition
characterized by high blood platelet counts. The FDA has not previously approved
a drug for this indication. AGRYLIN is indicated for the treatment of patients
with essential thrombocythemia to reduce the elevated platelet count and to
reduce the risk of thrombosis and to improve associated symptoms.
AGRYLIN is approvable under section 505(b) of the Federal Food, Drug and
Cosmetic Act and does not require any additional studies. Roberts is currently
in the process of preparing a marketing label to be submitted to the FDA which
is a prerequisite to marketing clearance.
The Company commented that marketing approval of AGRYLIN is a major
development for Roberts and should contribute to 1997 being a pivotal year in
the long-term growth of Roberts.
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: February 5, 1997 By: /s/ Anthony A. Rascio
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Anthony A. Rascio
Vice President