Lannett Receives FDA Approvals for Hydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg and 8 mg Strengths
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.
"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.
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.
This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statements, including, but not limited to, Lannett's ability to successfully commercialize Hydromorphone Hydrochloride Tablets, 2 mg, 4 mg and 8 mg strengths, whether expressed or implied, are subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the difficulty in predicting the timing or outcome of FDA or other regulatory approvals or actions, the ability to successfully commercialize products upon approval, Lannett's estimated or anticipated future financial results, future inventory levels, future competition or pricing, future levels of operating expenses, product development efforts or performance, and other risk factors discussed in the company's Form 10-K and other documents filed with the Securities and Exchange Commission from time to time. These forward-looking statements represent the company's judgment as of the date of this news release. The company disclaims any intent or obligation to update these forward-looking statements.
Robert Jaffe/Evan Pondel