Harrow Launches VIGAMOX in the U.S
VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5% is a fluoroquinolone antibiotic eye drop for the treatment of bacterial conjunctivitis.
www.ophthalmologyweb.comHere are the latest publicly available updates on Vigamox eye drops (moxifloxacin):
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U.S. availability and NDA transfer: Harrow announced the completion of transferring the NDA for Vigamox 0.5% to Harrow, and indicated plans to implement market access and other brand strategies now that the transfer is complete. This suggests Vigamox remains on the U.S. market under Harrow’s oversight [source indicating Harrow's NDA transfer and market plans].[1]
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Prescribing information highlights (common across sources): Vigamox is an ophthalmic antibiotic containing moxifloxacin 0.5%, dosed as one drop in the affected eye three times daily for seven days, used to treat bacterial conjunctivitis and related infections. Contraindications include hypersensitivity to moxifloxacin or other quinolones [U.S. labeling and prescribing information references].[3][6][8]
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Clinical efficacy and safety notes: In pivotal trials, Vigamox achieved clinical cure in a majority of patients by Days 5–6 when dosed for four days, with microbiological eradication rates in the 84–94% range for baseline pathogens; common ocular adverse events occur in a minority of patients (roughly 1–6%) and include conjunctival irritation and blurred vision, among others.[2][3]
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Branding and regulatory context: Vigamox has carried FDA-approved ophthalmic indications and is one of the established fluoroquinolone ophthalmic antibiotics. The product has historically been associated with Novartis and later transfers to other companies; current labeling remains consistent with 0.5% moxifloxacin ophthalmic solution.[5][6]
Notes and what I can’t confirm here:
- I don’t have access to real-time regulatory press releases beyond the cited sources, so for the very latest company press releases or market status changes after these documents, please check the companies’ official sites or FDA labeling updates directly.
- If you want, I can pull the latest FDA label PDFs or DailyMed entry snippets and summarize any new cautions, dosing changes, or new contraindications.
Would you like me to fetch the most recent FDA labeling or any specific country’s regulatory status for Vigamox? I can also tailor this to your location in São Paulo, Brazil, if you’re seeking local availability or Brazilian regulatory notes. Citations: Harrow NDA transfer news, labeling and dosing information, general product history (Novartis reference).[6][8][1][2][3][5]