Lannett Company, Inc. Receives FDA Approvals for Hydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg and 8 mg Strengths

Bookmark and Share

PHILADELPHIA--(BUSINESS WIRE)--Lannett Company, Inc. (NYSE AMEX: LCI) today announced that it has received approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Hydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg and 8 mg, the generic equivalent of Purdue Pharmaceuticals’ (formerly Abbott’s) Dilaudid® Tablets 2 mg, 4 mg and 8 mg. According to Wolters Kluwer, U.S. sales in 2008 of both generic and brand Hydromorphone Hydrochloride Tablets, 2 mg, 4 mg and 8 mg were $170 million at Average Wholesale Price. Lannett’s Cody Laboratories will manufacture the active pharmaceutical ingredient used in the company’s Hydromorphone products. Lannett expects to commence marketing within the next few weeks.

MORE ON THIS TOPIC