EATONTOWN, N.J., Sept. 9 /PRNewswire/ -- Roberts Pharmaceutical
Corporation (Nasdaq: RPCX) announced today 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 a press release of June 10, 1996, the Company announced receipt of an
FDA approvable 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.
Dr. Robert A. Vukovich, President and CEO of Roberts noted, "This is a
significant milestone for Roberts. ProAmatine is not only the first
cardiovascular drug cleared for marketing under the accelerated process, it is
also the first of our pipeline drugs to be launched into the U.S. market.
ProAmatine is a confirmation of the Company's abilities to develop and bring
its own proprietary drugs through the regulatory process. As an investment in
our future, we have also built a sales and marketing infrastructure with our
own sales force now poised for the commercialization of our pipeline."
Roberts Pharmaceutical Corporation is an international pharmaceutical
company focusing on the acquisition and development of late-stage drugs.
Roberts currently markets its products in seven countries and has operating
subsidiaries in the U.S., Canada, and the United Kingdom.
This release may contain forward-looking statements which reflect
management's current views of future events and operations. These forward-
looking statements are based on assumptions and external factors, including
assumptions relating to regulatory action and competing products. Any changes
in such assumptions or external factors could produce significantly different
results.
SOURCE Roberts Pharmaceutical Corporation
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CONTACT:
Stuart Levine, Director of Investor Relations
of Roberts Pharmaceutical Corporation, 908-389-1182, ext. 3064
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