ImprimisRx today announced the availability of Fortisite, which includes a patent-pending compounded combination of tobramycin 1.5% and vancomycin 5%.
According to a news release from the company, compounded topical antibiotic formulations may be appropriate to prescribe for patients with clinical needs that are unmet by FDA-approved drug products. Fortisite, which includes a compounded combination antibiotic formulation (tobramycin 1.5% and vancomycin 5%) in solution, is tested for both potency and sterility before it is dispensed, and uniquely, is stable at refrigerated temperatures (5°C) for up to 180 days.
The company noted that formulations are currently available for individual patients through the ImprimisRx 503A national mail order pharmacy. Once available through the ImprimisRx FDA-registered and FDA‑inspected 503B outsourcing facility, which is expected in the first half of 2023, physicians will be able, for the first time, to stock a fortified or high-concentration compounded antibiotic in their offices for the immediate treatment of patients-in-need.
In addition, consistent with its commitment to patient access, ImprimisRx will provide a robust Patient Access Program and a 100% replacement guarantee for any expired 503B Fortisite product, ensuring all U.S. eyecare professionals can continuously stock Fortisite formulations in their offices without the additional expense associated with expired product replacement.
Eyecare professionals interested in learning more about Fortisite can visit the ImprimisRx Boutique(Booth #4416) at the American Academy of Ophthalmology meeting.