FDA clears Lannett’s generic Levaquin oral solution
The Food and Drug Administration on Friday approved Lannett’s generic Levaquin oral solution (levofloxacin oral solution, 25 mg/ml). The Philadelphia-based company’s generic of Janssen’s drug is indicated to treat mild, moderate and severe infections caused by certain microorganisms.
The product had a market size of roughly $6 million for the 12 monthse ended April 2018, according to IQVIA data.
“Our [generic Levaquin oral solution] was approved three weeks ahead of the Target Action Date,” said Tim Crew, CEO 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.”
The product had a market size of roughly $6 million for the 12 monthse ended April 2018, according to IQVIA data.
“Our [generic Levaquin oral solution] was approved three weeks ahead of the Target Action Date,” said Tim Crew, CEO 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.”