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.
“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.”
"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.
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