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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):
January 8, 1998
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: 732-389-1182
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 submitted a regulatory application in the U.S. for approval to expand the
current indication for Agrylin/TM/ (anagrelide hydrochloride) to include
polycythemia vera, a chronic myeloproliferative disorder where an increase in
blood platelets is present.
In March 1997, the Company introduced and began marketing Agrylin/TM/ in
the United States as it was one of the Company's first FDA cleared drugs. The
current approved indication for Agrylin/TM/ is to treat essential
thrombocythemia.
Separately, a Product License Application has been filed with the
Medicines Control Agency in the United Kingdom seeking approval to market
ProAmatine/R/ (midodrine hydrochloride) for the treatment of orthostatic
hypotension. The application was submitted by Monmouth Pharmaceuticals, Ltd., a
wholly owned subsidiary of Roberts located in Guildford, England. ProAmatine/R/
is currently being marketed by Monmouth Pharmaceuticals, Ltd. in Ireland where
it is sold under the name Midon/R/ for treatment of orthostatic hypotension.
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: January 8, 1998 By: /s/ Anthony A. Rascio
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Anthony A. Rasio
Vice President
