LANNETT COMPANY COMMENTS ON FDA ACTION
Philadelphia, PA – April 1, 2009 – Lannett Company, Inc. (NYSE Amex: LCI) today said that it will continue to manufacture and market its Morphine Sulphate products, while it works with the U.S. Food and Drug Administration (FDA) to address the agency’s initiative on halting the marketing of certain narcotic drugs.
Lannett, along with a number of other drug manufacturers, received a warning letter from the FDA dated March 30, 2009 that stated the marketing of the company’s morphine products without an approved application constitutes a violation. Lannett was given 15 working days from the receipt of the letter to notify the FDA whether it plans to cease manufacturing and marketing the drugs referenced in the letter.
“Product safety is our No. 1 priority, and we want our customers to know that Lannett has been manufacturing and distributing its Morphine-based products for some time,” said Arthur Bedrosian, president and chief executive officer of Lannett Company. “Our Morphine-based products are manufactured under strict compliance with cGMP and fill an important healthcare need for patients suffering with pain.
“Certain Morphine-based products, such as ours, have been on the market and safely prescribed in the U.S., in some cases, for more than 100 years. We believe the FDA’s actions with regard to this matter are unprecedented and we intend to resolve this issue as soon as possible. That said, Morphine products currently constitute a relatively small percentage of our total revenues.”
About Lannett Company, Inc.:
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of indications. For more information, visit the company’s website at www.lannett.com.