Generics
Lannett awarded US FDA approval for Levofloxacin Oral Solution, with expected imminent launch
4 June 2018 -

Generic pharmaceutical company Lannett Company, Inc (NYSE:LCI) revealed on Friday the receipt of approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levofloxacin Oral Solution USP in 25 mg/ml.

The company said the Levofloxacin Oral Solution USP in 25 mg/ml is the therapeutic equivalent to the reference listed drug, Levaquin Oral Solution in 25 mg/ml of Janssen Pharmaceuticals Inc.

According to IMS, total US sales of Levofloxacin Oral Solution USP in 25 mg/ml was about USD6m, for the 12 months ended April 2018.

In addition, the ANDA for Levofloxacin Oral Solution, a paragraph IV product, was approved three weeks ahead of the Target Action Date and the expected near-term launch is further evidence of its growing operational effectiveness, said Tim Crew, chief executive officer of Lannett.

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