Medexus is working with Ethypharm to generate the data needed to support an abbreviated new drug application for triamcinolone hexacetonide.
To address a shortage of Aristospan (triamcinolone hexacetonide) injectable suspension, Medexus Pharma is coordinating with the FDA to import Hexatrione (triamcinolone hexacetonide), injectable suspension from France.
Manufactured and marketed by Ethypharm Laboratories, Hexatrione 2% is supplied in an auto-breakable pre-scored One Point Cut ampoule, which can be opened easily, reducing the risk of splintering and/or sharp edges. The imported product contains the same concentration of active substance and the same composition of excipients as Aristospan.
No other company except Medexus is authorized by the FDA to import or distribute triamcinolone hexacetonide in the United States. This is the second importation from France of triamcinolone hexacetonide. In March, the Medexus initiated a similar program to bring the product to the U.S. market.
Sandoz had discontinued Aristospan in 2016 and since that time, there has been a shortage of the therapy. Aristospan is indicated as an adjunctive therapy for short-term administration in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.
Medexus indicated in June 2021 that it is coordinating with Ethypharm, its licensing partner, to generate the data needed to support an abbreviated new drug application for triamcinolone hexacetonide. Medexus officials said in December 2020 at the time of the licensing agreement that triamcinolone hexacetonide has the potential to become the standard of care by offering a longer duration of action along with fewer injections, as well as a safer and more cost-effective solution. At that time, the company said that it expected to file for FDA approval within 12 to 24 months.