Lannett Nears FDA Approval; Awaits Facility Clearance (LCI)

Lannett Company LCI, a manufacturer of generic pharmaceuticals, today announced that it recently met with the U.S. Food and Drug Administration (FDA) to discuss the status of the company's New Drug Application (NDA) for Morphine Sulfate Oral Solution as well as other pending product applications. At the meeting, the FDA informed the company that it intends to conduct a Pre-approval Inspection (PAI) of Lannett's manufacturing facility as part of its review of the Morphine Sulfate NDA. “The FDA indicated to us that it will approve our Morphine Sulfate NDA and certain other pending product applications, subject to our manufacturing facility passing the PAI, which we expect to occur shortly.” The company said its manufacturing facilities were previously inspected by the FDA in January and February 2010, and it responded to the observations within seven days. The FDA conducted a follow-up inspection in September, resulting in zero observations at Lannett's plants in Philadelphia and a total of two minor 483 observations at its pain management products facility in Wyoming. Arthur Bedrosian, president and chief executive officer of Lannett, said, “The FDA indicated to us that it will approve our Morphine Sulfate NDA and certain other pending product applications, subject to our manufacturing facility passing the PAI, which we expect to occur shortly.”