FDA approves expanded indication for Melinta Therapeutics’ Baxdela
Melinta Therapeutics has received the Food and Drug Administration’s approval for Baxdela (delafloxacin) for the treatment of adult patients with community-acquired bacterial pneumonia, or CABP), caused by designated susceptible bacteria.
“We are pleased to announce the approval of BAXDELA for the treatment of CABP in adults,” said Jennifer Sanfilippo, Melinta interim CEO “As previously disclosed, we are closely managing our liquidity position and continue to evaluate our potential strategic and other alternatives. As such, while we believe that Baxdela will play a significant role in the treatment of this potentially life-threatening illness, we are delaying the commercial launch of CABP until we have greater insight into our ability to secure additional sources of liquidity.”
Baxdela was approved by the FDA in 2017 for the treatment of adult patients with acute bacterial skin and skin structure infections caused by designated susceptible bacteria.