The plea bargain settles a six-year investigation by the
Office of the U.S. Attorney in Los Angeles, the Costa Mesa,
California-based company said in a statement.
ICN said it agreed to plead guilty to a single felony count
for failing to disclose until, Feb. 17, 1995 a negative letter
received from the U.S. Food and Drug Administration (FDA) in
December 1994 on the status of the company's application for
Virazole, known generically as Ribavarin, as a stand-alone
treatment for chronic hepatitis C.
The FDA ultimately turned down the marketing application
and the drug was eventually approved for use in combination
with another hepatitis drug.
As a result of the plea bargain, ICN said it will be on
probation for three years. In return, the U.S. Attorney will
not prosecute or further investigate the company or its
officers, will close its investigation, and will not bring
additional charges.
Shares of ICN, which said it took reserves for the
settlement last year, were up 32 cents, or 1 percent, at
$31.26 late on the New York Stock Exchange.
ICN is also facing a U.S. Securities and Exchange
Commission civil lawsuit accusing it of misleading investors.
