ISA247, a calcineurin inhibitor currently in phase IIb in North America for the prevention of organ rejection in kidney transplant patients and as a treatment for uveitis, has received approval from the United States Adopted Names Council to call the drug voclosporin.
ISA247, a calcineurin inhibitor currently in phase IIb in North America for the prevention of organ rejection in kidney transplant patients and as a treatment for uveitis, has received approval from the United States Adopted Names Council to call the drug voclosporin. The next step is to request approval for the name by WHO?s International Nonproprietary Names (INN) committee. Once given the nod by INN, the drug will be referred to as voclosporin as its generic name in all future materials. Voclosporin is the lead candidate of Canadian company Isotechnika Inc.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.