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Health Canada grants approval for Pivotal to expand Omazen indication

Pivotal Therapeutics has received approval from Health Canada to expand the indication of Omazen's product line specifically for cardiovascular health.

Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD) has issued natural product number (NPN), NPN 80060196 and NPN 80060197 with the claim that helps to maintain and support cardiovascular health as well as normal serum/blood triglycerides/triacylglycerol levels.

Both the new products contain the same formulation and high purity as Omazen and will also be positioned for the professional markets such as Wellness Clinics, Cardiac Rehabilitation Clinics, Sports Medicine Clinics and Private Executive Healthcare Clinics.

Pivotal co-founder and chief scientific officer Dr George Jackowski said: "This is the first greater than 90% pure Omega-3 fatty acid prescription grade formulation in Canada with a claim to maintain and support triglyceride levels and cardiovascular health.

"Physicians to date can only prescribe fenofibrates which can damage the liver. This is the first natural alternative in Canada that is supported by clinical data for cardiovascular patients."

Omazen is the company’s second commercial product to market and is available for sale and distribution for the professional OTC market in Canada.