Commonly used muscle-building dietary supplements are under regulated in Canada

A new policy analysis, published in the journal Performance Enhancement & Health, highlights several gaps in current Canadian policy regulating muscle-building dietary supplements. Muscle-building dietary supplements, including whey protein, creatine monohydrate, and amino acids, are used based on purported benefits to muscular growth and recovery. These products are regulated by the Natural Health Products Regulations under Health Canada. “We identified many gaps […]

Livmarli receives Health Canada authorization for Alagille syndrome – Mirum Pharmaceuticals

Health Canada has authorized the use of maralixibat oral solution (Livmarli) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS), as recently announced by Mirum Pharmaceuticals. Health Canada’s authorization is based on data from the pivotal ICONIC study, which includes 6 years of data from the maralixibat clinical program. The study has provided robust evidence demonstrating statistically […]

Health Canada approves Xcopri to treat partial offset seizures – Paladin Labs

SK Biopharmaceuticals said that Health Canada granted a Notice of Compliance for Xcopri (ingredient: cenobamate), its epilepsy drug, approving its application for marketing authorization in Canada. Paladin Labs, a local pharmaceutical company, will be in charge of commercializing the product in Canada. Xcopri is the first locally-developed epilepsy drug to score FDA approval, with the entire drug development process from […]

Approval of Zynrelef by Health Canada for the management of postoperative pain – Heron Therapeutics

Heron Therapeutics, Inc., announced that Health Canada has issued a Notice of Compliance (NOC) to commercialize Zynrelef (bupivacaine and meloxicam extended-release solution) for instillation into the surgical wound for postoperative analgesia after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty surgical procedures. Based on prior agreements with the FDA, Heron already has clinical studies underway, which it plans to submit […]

Health Canada approves Abecma for multiple myeloma – BMS

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