Lannett Company Expecting Facility Approval Soon (LCI)

Rumors surfaced on Tuesday that Lannett Company LCI was very close to receiving FDA approval for its New Drug Application (NDA) for Morphine Sulfate Oral Solution, with some rumors suggesting that Lannetts Cody laboratory facility has been passed by the FDA.

Lannett's New Drug Application (NDA) for 505(b)(2) was originally filed on February 26, 2010, and the FDA announced at the start of February that it was conducting pre-approval-inspections with completion expected during 1Q11.

On Tuesday, Lannett said during a conference call that the inspection was nearing completion, and that nothing negative had occurred so far during FDA visits. Whether the facility passed the inspection is yet to be confirmed, but all reports currently suggest that FDA approval is not too far away for Lannett's NDA.