Lannett Receives Fda Approval For Morphine Sulfate Oral Solution Nda
Philadelphia, PA – June 24, 2011 – Lannett Company, Inc. (NYSE AMEX: LCI) today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s 505(b)(2) New Drug Application (NDA) for Morphine Sulfate Oral Solution on June 23, 2011. Sales of Morphine Sulfate Oral Solution for the last 12 months at Average Wholesale prices (AWP) were approximately $31.7 million,
according to Wolters Kluwer. The company expects to commence shipping the product shortly.
“This is first drug approval Lannett has received using a 505(b)(2) application,” said Arthur P. Bedrosian, president and chief executive officer of Lannett. “We applaud the dedicated efforts or our team and thank our shareholders for their patience and faith in our ability to re-launch this important medication.”
Bedrosian went on to say that the company is expecting to receive approvals for a number of Abbreviated New Drug Applications (ANDAs) currently pending at the FDA, and looks forward to working with the agency, both locally and in Maryland, on other 505(b)(2) NDA filings.
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 and market acceptance and demand 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.