Amikacin liposome inhalation suspension, sponsored by Insmed, Inc., for the proposed indication of treatment of nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex in adults as part of a combination antibacterial drug regimen
Read MoreJUL 26 AMDAC
Tafenoquine tablet, 100 milligram (mg), sponsored by 60 Degrees Pharmaceuticals, for the proposed indication of prevention of malaria in adults for up to 6 months of continuous dosing
Read MoreJUL 12 AMDAC
Tafenoquine tablet, 150 milligram, sponsored by GlaxoSmithKline, for the proposed indication of the radical cure (prevention of relapse) of Plasmodium vivax malaria
Read MoreAUG 8 AMDAC
Omadacycline tablets and injection, sponsored by Paratek Pharmaceuticals, Inc., for the proposed indications for the treatment of community acquired bacterial pneumonia and acute bacterial skin and skin structure infections
Read MoreMAY 1 AMDAC
Tecovirimat, by SIGA Technologies Inc., for the treatment of smallpox
Read MoreMAY 2 AMDAC
Plazomicin, by Achaogen,Inc., for the proposed indications for the treatment of complicated urinary tract infections and blood stream infections
Read MoreJAN 11 AMDAC
Ciprofloxacin dispersion for inhalation by Aradigm Corp.
Read MoreFEB 14 AADPAC
sNDA for EXPAREL (bupivacaine liposomal injectable suspension) by Pacira Pharmaceuticals, Inc., to produce local analgesia and as a nerve block to produce regional analgesia
Read MoreJAN 11 AMDAC
Ciprofloxacin dispersion for inhalation by Aradigm Corp.
Read MoreJAN 11 AMDAC
Ciprofloxacin dispersion for inhalation by Aradigm Corp.
Read MoreNOV 16 AMDAC
Ciprofloxacin inhalation powder by Bayer
Read MoreNOV 16 AMDAC
Ciprofloxacin inhalation powder by Bayer
Read MoreAPR 13 AMDAC
Development of antibacterial drugs that treat a single species of bacteria when the target species infrequently causes infections
Read MoreAPR 13 AMDAC
Development of antibacterial drugs that treat a single species of bacteria when the target species infrequently causes infections
Read MoreNOV 4 AMDAC
Cempra Pharmaceuticals' solithromycin capsules & injection for community-acquired bacterial pneumonia
Read MoreNOV 4 AMDAC
Cempra Pharmaceuticals' solithromycin capsules & injection for community-acquired bacterial pneumonia
Read MoreJUN 9 AMDAC
Merck's bezlotoxumab for the prevention of Clostridium difficile (C. diff) infection recurrence
Read MoreJUN 9 AMDAC
Merck's bezlotoxumab for thethe prevention of Clostridium difficile (C. diff) infection recurrence
Read MoreNOV 5 AMDAC-DSRM
Risks and benefits of systemic fluoroquinolone antibacterial drugs for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease (ABECB-COPD), and uncomplicated urinary tract infections (uUTI)
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