EATONTOWN, N.J., Feb. 3 /PRNewswire/ -- Roberts Pharmaceutical Corporation
(Nasdaq-NNM: RPCX) announced today that it has received notification from the
Food and Drug Administration (FDA) that the Company's New Drug Application for
AGRYLIN(TM) is approvable.
AGRYLIN (anagrelide hydrochloride) has been developed by Roberts for the
treatment of essential thrombocythemia, a life threatening condition
characterized by high blood platelet counts. The FDA has not previously
approved a drug for this indication. AGRYLIN capsules are indicated for the
treatment of patients with essential thrombocythemia to reduce the elevated
platelet count and to reduce the risk of thrombosis and to improve associated
symptoms.
AGRYLIN is approvable under section 505(b) of the Federal Food, Drug and
Cosmetic Act and does not require any additional studies. As a normal
prerequisite to marketing clearance, Roberts will submit to FDA copies of the
product's final printed labeling. That process has already been initiated and
the Company anticipates marketing the product in the near term.
Commenting on this approval, Dr. Robert A. Vukovich, President and CEO,
said "This is a major development for Roberts. The AGRYLIN approval follows
closely on the heels of the recent launch of our first pipeline drug
PROAMATINE(TM)." He continued by noting, "With our first two proprietary
drugs now becoming available to our sales force, 1997 should prove to be a
pivotal year in the long-term growth outlook for Roberts."
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 and past news releases by Roberts Pharmaceutical Corporation are
available through PR Newswire's Company News On-Call fax service at
1-800-758-5804, extension 760975 and on the internet at
http://www.prnewswire.com.
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 Z. Levine, Ph.D., Director of Investor Relations of Roberts Pharmaceutical, 908-389-1182, ext. 3064
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