Dec 11 2009
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.
http://www.lannett.com/