May 24 Drugmaker Forest Laboratories
received a subpoena earlier this month from U.S. prosecutors
requesting documents relating to its small-selling lung disorder
product, the Tudorza Pressair inhaler, the company said in a
The New York-based company said it was cooperating with the
request in the May 6 subpoena. It did not respond to a request
for further comment. A spokeswoman for the U.S. Attorney's
Office in New York also declined to comment.
The subpoena, which came from the U.S. Attorney for the
Southern District of New York, was noted briefly in the
company's annual 10-k filing with the Securities and Exchange
Tudorza Pressair is used to treat spasms associated with
chronic obstructive pulmonary disease, including chronic
bronchitis and emphysema. The product had sales of $23 million
for the fiscal year ending March 31.
There were no other details of the nature of the
investigation in the filing, but this is not the first time
Forest has come under scrutiny from U.S. authorities.
In 2010, it paid more than $300 million, including $150
million in criminal fines, for selling a thyroid disorder drug
without first obtaining U.S. Food and Drug Administration
approval, and for promoting its big-selling antidepressant
Celexa for use in children when it was only approved for adults.
In addition to criminal and civil fines, Forest pleaded
guilty to one felony count of obstructing justice, one
misdemeanor count of distributing an unapproved new drug in
interstate commerce and one misdemeanor count of distributing a
misbranded drug in interstate commerce.
Forest also signed a Corporate Integrity Agreement with the
Department of Health and Human Services, Office of Inspector
General, related to its sales and marketing practices.
Forest, which was in a bitter proxy battle with billionaire
activist investor Carl Icahn last year, said on Thursday that
Chief Executive Officer Howard Solomon would retire at the end
of this year after more than 35 years of running the drugmaker.
Icahn has criticized the company for being ill-prepared to
generate new growth as generic competition curtails revenue from
two of its biggest-selling treatments - Lexapro for depression
and Namenda for Alzheimer's disease.
Forest had also been under fire for a lack of succession
planning. The company said it has been evaluating internal and
external candidates for the top job.