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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):
June 10, 1996
ROBERTS PHARMACEUTICAL CORPORATION
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(exact name of registration 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 the Food
and Drug Administration (FDA) has issued an approvable letter stating the
Company's New Drug Application for ProAmatine(TM) (midodrine) "is approvable
under 21 CFR Subpart H - Accelerated approval of new drugs for serious or life
threatening illnesses".
ProAmatine, developed by Roberts to fill the U.S. therapeutic void in
the treatment of orthostatic hypotension (a low blood pressure condition), would
be the first cardiovascular drug to be approved by the accelerated process.
ProAmatine has also been designated an "orphan drug" by the FDA and as such is
entitled to seven years marketing exclusivity, commencing with the product's
launch.
No other studies are required prior to commercialization, although
Roberts will conduct post-approval, post-launch studies of ProAmatine with
regard to certain specific symptoms 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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Date: June 14, 1996 By: /s/ Anthony A. Rascio
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Anthony A. Rascio
Vice President
