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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):
September 9, 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 the Food and Drug
Administration (FDA) has cleared ProAmatine/TM/ (midodrine hydrochloride) for
U.S. marketing. The Company anticipates the U.S. launch of ProAmatine shortly.
In an earlier press release, the Company announced receipt of an FDA
approval letter noting that "ProAmatine is approvable under 21 CFR Subpart H --
Accelerated approval on new drugs for serious or life-threatening illnesses".
Roberts further noted that ProAmatine, which had been developed to fill the U.S.
therapeutic void in the treatment of orthostatic hypotension (a low blood
pressure condition), was approvable based on a surrogate endpoint, i.e.,
standing blood pressure. As required by regulations, Roberts then submitted
labeling and promotional material to FDA for review as a prerequisite to
marketing. That step of the review process has now been completed and Roberts is
preparing for the near-term launch of ProAmatine.
The Company also noted that ProAmatine is not only the first
cardiovascular drug cleared for marketing under the accelerated process, it is
also the first of Roberts, pipeline drugs to be approved for sale in the U.S.
market.
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: September 11, 1996 By: /s/ Anthony A. Rascio
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Anthony A. Rascio
Vice President
