Isotechnika receives USAN approval for generic name for lead immunosuppressive drug
EDMONTON, Mar 12, 2007 (Canada NewsWire via COMTEX News Network) --
Isotechnika Inc. announced today that the Company has received approval from United States Adopted Name (USAN) for naming of its lead immunosuppressive drug, ISA247.
The name, voclosporin, is now being reviewed by the International Nonproprietary Name (INN) expert committee. The INN is scheduled to publish the proposed list of approved names sometime in mid 2007. Official notification from the INN would allow Isotechnika to use the name voclosporin in labelling, publications, and on drug information. The name will serve to identify the active pharmaceutical substance during the drugs' life-time worldwide.
ISA247 (voclosporin) is a calcineurin inhibitor, currently being investigated in a Phase 3 European/Canadian trial for the treatment of moderate to severe psoriasis and a Phase 2b North American trial for the prevention of organ rejection in kidney transplant patients and as a treatment for uveitis in three separate pivotal Phase 2/Phase 3 trials. The latter trial is being coordinated by our partner, Lux Biosciences.
"Moving toward the name of voclosporin from the previous nomenclature of ISA247 should assist us in initiating our commercial branding process. The next step in the naming process is to request that the USAN approved name, voclosporin, be approved by the International Nonproprietary Name (INN) Programme of the World Health Organization (WHO). Pending receipt of this INN approval, ISA247 will, in all future materials, be referred to by its new generic name, voclosporin," commented Dr. Randall Yatscoff, Isotechnika's President & CEO |
