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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):
May 17, 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 they have
agreed with the Food and Drug Administration (FDA) to explore the approval of
ProAmatine(TM) (midodrine) under regulations for the "Accelerated Approval of
New Drugs for Serious Life-Threatening Illnesses". ProAmatine is a new
cardiovascular agent for orthostatic hypotension, a low blood pressure condition
for which the FDA has not previously approved any drug.
According to the Accelerated Approval process, the FDA could approve
ProAmatine based on a surrogate endpoint for orthostatic hypotension such as the
clinically demonstrated ability of ProAmatine to increase blood pressure. In
turn, Roberts would commit to providing the FDA with additional data on
ProAmatine's efficacy in relieving specific symptoms of orthostatic hypotension.
On March 26, 1996, Roberts announced that the FDA had requested
additional information with regard to the Company's New Drug Application for
ProAmatine. The FDA has reconsidered this position and has agreed to discuss
Accelerated Approval which, if granted, would allow Roberts to provide such
information through a post-marketing Phase IV study. The Company and the FDA
have further agreed to meet as soon as possible in order to pursue expeditiously
the potential Accelerated Approval for ProAmatine.
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: May 20, 1996 By: /s/ Anthony A. Rascio
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Anthony A. Rascio
Vice President
