NDAINTRAVENOUSPOWDERPriority Review
Approved
Jun 2017
Lifecycle
Peak
Competitive Pressure
0/100
Mechanism of Action
12.1 Mechanism of Action BAXDELA is an antibacterial drug [see ] . 12.2 Pharmacodynamics The antibacterial activity of delafloxacin appears to best correlate with the ratio of area under the concentration-time curve of free delafloxacin to minimal inhibitory concentration ( f AUC/MIC) for…
Indications (20)
skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA]methicillin-susceptible [MSSA] isolates)Staphylococcus haemolyticusStaphylococcus lugdunensisStreptococcus agalactiaeStreptococcus anginosus Group (including Streptococcus anginosusStreptococcus intermediusStreptococcus constellatus )Streptococcus pyogenesEnterococcus faecalisEscherichia coliEnterobacter cloacaeKlebsiella pneumoniaePseudomonas aeruginosaStaphylococcus aureus (methicillin-susceptible [MSSA] isolates only)Haemophilus influenzaeHaemophilus parainfluenzaeChlamydia pneumoniaeLegionella pneumophilaMycoplasma pneumoniae
Loss of Exclusivity
LOE Date
Jun 2, 2034
100 months away
Patent Expiry
Jun 2, 2034
Exclusivity Expiry
Jun 19, 2027