Lannett Company, Inc, a manufacturer of generic pharmaceuticals, has received approval from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Ursodiol 300 mg capsules, the generic equivalent of Actigall marketed by Watson Pharmaceuticals. According to Wolters Kluwer, combined sales of generic and brand Ursodiol were $128.2 million for the 12 months ending October 2008.
Ursodiol is indicated for patients with radiolucent noncalcified gallbladder stones, and for the prevention of gallstone formation in obese patients experiencing rapid weight loss. "The approval of Ursodiol expands our product offering and adds to the significant number of product approvals Lannett has received thus far in 2008," said Arthur Bedrosian, president and chief executive officer of Lannett. "We continue to build a robust, diversified pipeline and remain optimistic that our growth strategy will continue to pay dividends. Our accomplishments this year are the result of the hard work and dedication of our employees."
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of indications.