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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):
March 26, 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 requested additional information regarding the
Company's New Drug Application for ProAmatine(TM) (midodrine).
The FDA notes that while midodrine has a clear pressor effect in both the
supine and standing position, further data are needed before the drug can be
approvable for orthostatic hypotension (a low blood pressure condition). The
Company is reviewing the details of the FDA's request and how to satisfy the
apparent deficiency. To date, the FDA has not approved any drug for orthostatic
hypotension. A definitive clinical methodology for testing a drug for this
indication has never been established by the FDA.
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: April 1, 1996 By: /s/ Anthony A. Rascio
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Anthony A. Rascio
Vice President
