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 filing.
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 Commission.
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.
(Reporting by Deena Beasley and Bill Berkrot; Editing by Leslie Gevirtz)