FDA approves Lannett's Hydromorphone Hydrochloride Tablets

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.

“These approvals for Hydromorphone are an important step in our plan to become a vertically integrated leader in the pain management field,” said Arthur Bedrosian, Lannett’s president and chief executive officer. “We have made a significant investment in Cody Laboratories to participate in this market and intend to be a major player over time.

“Currently, market shortages exist for Hydromorphone. We believe we can capture a substantial portion of the market for Hydromorphone as only one other supplier of Hydromorphone has all three dosage strengths.”

Bedrosian said other suppliers of Hydromorphone in the U.S. have ceased manufacturing the product or do not produce all three dosage strengths.

Hydromorphone Hydrochloride tablets are indicated for the management of pain in patients where an opioid analgesic is appropriate.