New Levofloxacin Product Approved by FDA

Officials with the FDA have approved Lannett Company’s Abbreviated New Drug Application (ANDA) for Levofloxacin Oral Solution USP, 25 mg/mL, the therapeutic equivalent to the reference listed drug, Levaquin Oral Solution, 25 mg/mL, of Janssen Pharmaceuticals, Inc.¹

Levofloxacin is a fluoroquinolone antibiotic medicine used in adults aged 18 years and older to treat certain bacterial infections, including some types of pneumonia and bronchitis. Chronic prostate infection, urinary tract infection, uncomplicated acute kidey infection, sinus infection and skin infections also can be treated with levofloxacin. In addition, the drug is used to treat inhalation anthrax and plague.²

"Our ANDA for Levofloxacin Oral Solution, a paragraph IV product, was approved 3 weeks ahead of the Target Action Date," said Tim Crew, CEO of Lannett, in a statement.¹ "While the commercial opportunity for our levofloxacin product is modest, the expected near-term launch is further evidence of our growing operational effectiveness. We continue to make progress unlocking the value of our many approved products pending launch and expect to announce additional product launches in the coming months."

References

• Lannett Receives FDA Approval For Levofloxacin Oral Solution; Imminent Launch Anticipated [news release]. Philadelphia, PA: June 1, 2018; Cision PR Newswire website. https://www.prnewswire.com/news-releases/lannett-receives-fda-approval-for-levofloxacin-oral-solution-imminent-launch-anticipated-300657975.html#. Accessed June 5, 2018.
• U.S Food and Drug Administration. Medication guide: Levaquin (levofloxacin ). FDA website. Lhttps://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf. Accessed June 5, 2018.