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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 31, 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 been
informed that the Food and Drug Administration (FDA) will shortly issue an
"approvable letter" for ProAmatine (TM) (midodrine) pursuant to Subpart H
regulations for "Accelerated Approval of New Drugs For Serious Or
Life-Threatening Illnesses". PromAmatine would be the first cardiovascular
drug to be approved by the FDA under the accelerated process.
ProAmatine, which the FDA has designated as an "orphan drug",
has been developed by Roberts to fill the U.S. therapeutic void in the
treatment of orthostatic hypotension.
A meeting of the Company and FDA took place on May 22, 1996 to
discuss accelerated approval of ProAmatine. The FDA has now agreed that, under
the accelerated process, ProAmatine is eligible for approval based on a
surrogate endpoint for orthostatic hypotension, i.e., the drug's clinically
demonstrated ability to increase blood pressure. In turn, Roberts has agreed to
perform post-marketing Phase IV studies to satisfy the FDA's request for
additional studies to verify clinical benefit. Roberts and FDA will meet again
to discuss the final design of the Phase IV protocols. Meanwhile, Roberts will
initiate pre-launch activities, including the preparation of its U.S. sales
force in anticipation of FDA clearance of the product.
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: June 4, 1996 By:/s/ Anthony A. Rascio
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Anthony A. Rascio
Vice President
