FDA approves Xenleta for community-acquired bacterial pneumonia
The US Food and Drug Administration on Monday approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia, in both oral and intravenous formulations.
The FDA granted the approval of Xenleta to Nabriva Therapeutics (Nasdaq: NBRV), whose shares leapt 22.7% to $2.70 in pre-market trading this morning.
The company said the injectable would have a list price of $205 per day, and the oral version would be $275 per day.
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