Harrow announced the availability of Fortisite (compounded Tobramycin 1.5% + Vancomycin 5%) for in-office use from its FDA-registered and FDA-inspected ImprimisRx 503B outsourcing facility. Fortisite formulations are high-concentration, refrigeration-stable, fortified antibiotic formulations in solution that are patent-pending.
According to Harrow, the availability of Fortisite for in-office use marks the first time that eye care providers have had access to a fortified or high-concentration compounded antibiotic formulation for the immediate treatment of patients.
ImprimisRx provides a Fortisite patient access program as well as a 100% replacement guarantee for any expired 503B Fortisite medication, guaranteeing that all prescribing US eye care providers can keep Fortisite formulations in their clinics at all times. Fortisite can be ordered online or by calling ImprimisRx customer service at (844) 446-6979.
“The availability of Fortisite formulations will provide eye care professionals with new and important tools in their pharmaceutical armamentarium as they consider how to treat potentially sight-threatening infections," Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said in a news release. "Until there is an FDA-approved product to meet these needs, Fortisite formulations have the potential to become the standard of care for ophthalmology and optometry practices across the country.
“Because Fortisite is now available for in-office use from our FDA-registered 503B outsourcing facility, each bottle must strictly adhere to rigorous analytical testing protocols that are not required for locally regulated 503A compounding pharmacies," Mr. Baum said.