This NDA transfer marks the fourth FDA-approved ophthalmic product purchased by Harrow earlier in 2023 now commercially available in the US.
Harrow announced the completion of the New Drug Application (NDA) transfer of moxifloxacin hydrochloride ophthalmic solution 0.5% (Vigamox), making the drug commercially available in the United States under the Harrow name. Vigamox is a fluoroquinolone antibiotic eye drop for the treatment of bacterial conjunctivitis caused by susceptible strains of organisms.1 Earlier this year, Harrow bought the US commercial rights to 5 branded ophthalmic products—Ilevro, Nevanac, Vigamox, Maxidex, and Triesence—making this NDA transfer completion the fourth FDA-approved product from the acquisition.2
“Having now completed the NDA transfer of Vigamox, we are excited to begin the implementation of the market access, marketing, inventory management, national sales detailing, and other brand‑leveraging strategies that we have developed during this transfer period,” said Mark L. Baum, Chief Executive Officer of Harrow.
“With an exceptional record of safety and efficacy, Vigamox is a well-known, reliable, and trusted product by US eye care professionals, many of whom regard Vigamox as the preferred broad-spectrum topical antibiotic to treat patients for bacterial conjunctivitis (sometimes referred to as 'pink eye') as well as many other common bacterial-based infections.”
Vigamox can now be ordered directly through Cardinal’s Cordlogistics, who partners with Harrow on product orders, including a wholesaler distribution system with McKesson and AmerisourceBergen.
Moxifloxacin hydrochloride ophthalmic solution 0.5% (Vigamox) is a topical fluoroquinolone anti-infective to treat bacterial conjunctivitis caused by strains of the following organisms: Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, and Chlamydia trachomatis.1
*Efficacy for this organism was studied in fewer than 10 infections.
Vigamox is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.1
Conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing were the most frequently reported ocular adverse events, reported in 1-6% of patients.
Nonocular adverse events including fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis were reported in 1%-4% of patients.
For complete product information about Vigamox, including important safety information, please visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ad783689-2b59-448c-b0d6-e8b70cf8b062.