Lannett Company, Inc. (LCI) Announces Revised FDA PDUFA Date for Morphine Sulfate Oral Solution NDA
6/7/2011 7:00:11 AM
PHILADELPHIA--(BUSINESS WIRE)-- Lannett Company, Inc. (NYSE AMEX: LCI) announced today that the U.S. Food and Drug Administration (FDA) has issued a revised Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2011 for the company’s 505(b)(2) New Drug Application for Morphine Sulfate Oral Solution.
“With a revised PDUFA date in 17 days, we are preparing for the re-launch of our Morphine Sulfate Oral Solution product, if approved,” said Arthur Bedrosian, president and chief executive officer of Lannett.
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, the re-launch of Morphine Sulfate Oral Solution, 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.