Lannett Company, Inc. today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its 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. For the 12 months ended April 2018, total U.S. sales of Levofloxacin Oral Solution USP, 25 mg/mL, was approximately $6 million, according to IMS.
“Our ANDA for Levofloxacin Oral Solution, a paragraph IV product, was approved three weeks ahead of the Target Action Date,” said Tim Crew, chief executive officer of Lannett. “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.”
About Lannett Company, Inc.:
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. For more information, visit the company’s website at www.lannett.com.