Moxifloxacin Ophthalmic Solution (Page 2 of 2)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to determine the carcinogenic potential of moxifloxacin have not been performed. However, in an accelerated study with initiators and promoters, moxifloxacin was not carcinogenic in rats following up to 38 weeks of oral dosing at 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose for a 50 kg person, on a mg/kg basis ).

Moxifloxacin was not mutagenic in four bacterial strains used in the Ames Salmonella reversion assay. As with other quinolones, the positive response observed with moxifloxacin in strain TA 102 using the same assay may be due to the inhibition of DNA gyrase. Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay. An equivocal result was obtained in the same assay when v79 cells were used. Moxifloxacin was clastogenic in the v79 chromosome aberration assay, but it did not induce unscheduled DNA synthesis in cultured rat hepatocytes. There was no evidence of genotoxicity in vivo in a micronucleus test or a dominant lethal test in mice.

Moxifloxacin had no effect on fertility in male and female rats at oral doses as high as 500 mg/kg/day, approximately 21,700 times the highest recommended total daily human ophthalmic dose. At 500 mg/kg orally there were slight effects on sperm morphology (head-tail separation) in male rats and on the estrous cycle in female rats .

14 CLINICAL STUDIES

In two randomized, double-masked, multicenter, controlled clinical trials in which patients were dosed 3 times a day for 4 days, moxifloxacin ophthalmic solution produced clinical cures on day 5-6 in 66% to 69% of patients treated for bacterial conjunctivitis. Microbiological success rates for the eradication of baseline pathogens ranged from 84% to 94%.
In a randomized, double-masked, multicenter, parallel-group clinical trial of pediatric patients with bacterial conjunctivitis between birth and 31 days of age, patients were dosed with moxifloxacin ophthalmic solution or another anti-infective agent. Clinical outcomes for the trial demonstrated a clinical cure rate of 80% at Day 9 and a microbiological eradication success rate of 92% at Day 9.
Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.

16 HOW SUPPLIED/STORAGE AND HANDLING

Moxifloxacin ophthalmic solution USP, 0.5% is supplied as a sterile ophthalmic solution in 5 mL round screw neck bottle made with natural low density polyethylene and pump with a dip tube made with natural low density polyethylene and tan brown opaque screw cap made with high density polyethylene.
3 mL in a 5 mL bottle — NDC 72266-158-01
Storage: Store at 2°C to 25°C (36°F to 77°F).

17 PATIENT COUNSELING INFORMATION

Risk of Contamination: Advise patients not to touch the dropper tip to any surface to avoid contaminating the contents.

Concomitant Use of Contact Lenses: Advise patients not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.

Potential for Hypersensitivity Reactions: Systemically administered quinolones including moxifloxacin have been associated with hypersensitivity reactions, even following a single dose. Instruct patients to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction. [see Warnings and Precautions (5.2)].

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STERILE
Moxifloxacin Ophthalmic Solution, USP 0.5%
3 mL
Carton Label moxi-carton.jpg

moxi-label.jpg

MOXIFLOXACIN OPHTHALMIC SOLUTION moxifloxacin ophthalmic solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72266-158 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MOXIFLOXACIN HYDROCHLORIDE (MOXIFLOXACIN) MOXIFLOXACIN 5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BORIC ACID HYDROCHLORIC ACID SODIUM CHLORIDE SODIUM HYDROXIDE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72266-158-01 1 BOTTLE in 1 CARTON contains a BOTTLE 1 3 mL in 1 BOTTLE This package is contained within the CARTON (72266-158-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208778 08/24/2020

Labeler — Fosun Pharma USA Inc. (080920998)

Registrant — Gland Pharma Limited (918601238)

Revised: 08/2020 Fosun Pharma USA Inc.