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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):
July 9, 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 it has
submitted a Manufacturing Authorization Application (MAA) for European
approval of its new drug Agrylin/TM/. The application has been filed with
the European Medicines Evaluation Agency (EMEA) in accordance with the
centralized procedure for approval of new drugs within the 15-country
European Union (EU).
Agrylin (anagrelide HC1) is indicated for treating essential
thrombocythemia, a life-threatening condition characterized by elevated blood
platelet levels. The EU regulatory authorities have accepted Agrylin as a
"List B" product, a category given to products considered to represent new
drug treatments or important therapeutic advances.
Under the European centralized procedure, a successful MAA grants product
approval throughout the EU, a market potential for Agrylin that could
significantly exceed that of North America.
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: July 9, 1997 By: /s/ Anthony A. Rascio
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Anthony A. Rascio
Vice President
