Regulatory Decision Summary for Kadian

This Supplement to a New Drug Submission was filed by BGP Pharma ULC to obtain market authorization for Kadian (morphine sulfate) to add a dose strength of 200 milligrams (mg) and to align with the Product Monograph Master Template. Upon review of the submitted data package, Health Canada authorized Kadian and issued a Notice of Compliance.

This Supplement to a New Drug Submission was filed to add a 200 milligram (mg) strength capsule. The 200 mg strength falls within the recommended dosage for Kadian when used under certain conditions.

The Product Monograph was updated to the newest version of the Master Template, and safety-related information was added to align with the most current class labelling for opioid drug products.

Overall, the benefit-harm-uncertainty profile remained unchanged for Kadian 10 mg, 20 mg, 50 mg, 100 mg, and 200 mg for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance was recommended.

The new 200 mg strength is manufactured via encapsulating the extended-release pellets into the hard gelatin capsules. The pellets are the same as those being used for the approved strengths. A waiver of the requirement to perform comparative in vivo bioequivalence studies was granted for the 200 mg strengths. The quality recommendations of Health Canada’s policy document Bioequivalence of Proportional Formulations - Solid Oral Dosage Forms have been met.

The labelling documents conform to the necessary regulatory requirements and are consistent with the labelling guidance documents. The submission was considered acceptable with respect to the labelling documents reviewed.

For further details about Kadian, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.