Levofloxacin Injection Concentrate and Migalastat Hydrochloride

• Generic Name: levofloxacin
• Dosage Forms: injection, solution, concentrate
• Other Brand Names: Levaquin

Levofloxacin is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic that fights bacteria in the body. Levofloxacin is used to treat different types of bacterial infections. Levofloxacin is also used to treat people who have been exposed to anthrax or certain types of plague.

Fluoroquinolone antibiotics can cause serious or disabling side effects that may not be reversible. Levofloxacin should be used only for infections that cannot be treated with a safer antibiotic.

Levofloxacin may also be used for purposes not listed in this medication guide.

• Generic Name: migalastat
• Dosage Forms: n.a.
• Other Brand Names: Galafold

Migalastat hydrochloride is an alpha-galactosidase A (alpha-Gal A) pharmacological chaperone indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.

This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.