gatifloxacin

FDA Drug Profile — Gatifloxacin, ZYMAXID

Drug Details

Generic Name
gatifloxacin
Brand Names
Gatifloxacin, ZYMAXID
Application Number
ANDA204227
Sponsor
Sandoz Inc
NDC Codes
2
Dosage Forms
SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients
GATIFLOXACIN

Indications and Usage

1 INDICATIONS AND USAGE Gatifloxacin ophthalmic solution 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: • Aerobic gram-positive bacteria Staphylococcus aureus Staphylococcus epidermidis Streptococcus mitis group * Streptococcus oralis * Streptococcus pneumoniae • Aerobic gram-negative bacteria Haemophilus influenzae * Efficacy for these organisms were studied in fewer than 10 infections. Gatifloxacin ophthalmic solution is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group , Streptococcus oralis, Streptococcus pneumoniae ( 1 )