Regulatory Decision Summary for Desflurane
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
This Abbreviated New Drug Submission (ANDS) was filed to obtain market authorization for a generic version of the Canadian Reference Product (CRP) Suprane (desflurane inhalation anaesthetic) marketed by Baxter Corporation. Desflurane is an inhalation anesthetic with the following indications:
- Indicated as an inhalation agent for maintenance of general anesthesia following induction with agents other than Desflurane (desflurane) in adults.
- Geriatrics (>65 years of age): The minimum alveolar concentration (MAC) of Desflurane decreases with increasing patient age. The dose should be adjusted accordingly.
- Pediatrics: Desflurane is indicated as an inhalation agent for maintenance of general anesthesia following induction with agents other than Desflurane and subsequent endotracheal intubation in pediatric patients.
Desflurane is not recommended for mask induction of anesthesia in adults because of a high incidence of moderate to severe upper airway adverse events.
Desflurane should be administered only by persons trained in the administration of general anesthesia, using a vaporizer specifically designed and designated for use with desflurane. The facilities and equipment for maintenance of a patent airway, artificial ventilation, oxygen enrichment and circulatory resuscitation must be immediately available. Hypotension and respiratory depression increase as anesthesia is deepened.
The Active Pharmaceutical Ingredient (API) in the CRP, Suprane is produced from a conventional chemical, synthetic process, whereas Desflurane by Blue-Zone Technologies Ltd. is a unique, patented process for manufacturing the API. The process starts with the collection of the starting materials, which are halogenated inhalation anaesthetic gases recovered from a scavenging/recovery system at a hospital using a selective patented canister. Following their collection in the canisters, these materials are subject to in-house processing and purification steps to obtain pure Desflurane.
Why was the decision issued?
This drug product is eligible as an application for marketing authorization via the ANDS pathway. The drug product was found to meet the regulatory definition as a pharmaceutical equivalent to the CRP as it contains an identical amount of the identical medicinal ingredient in a comparable dosage form. In addition, it is administered via the same route of administration as the CRP.
In light of the conclusion of the comparability of the relevant pharmaceutical characteristics (i.e., (i) formulation (100% Desflurane), (ii) physicochemical properties, (iii) impurity profile and (iv) device attributes) between Desflurane by Blue-Zone Technologies Ltd. and the CRP, a waiver of the requirement to conduct comparative in vivo bioequivalence studies was granted.
The drug substance, Desflurane, is a chemical substance and, as such, the evaluation of this drug submission was led by the review programme responsible for pharmaceutical drugs. However, due to the nature of the starting material source for the generic drug product, the aspect of potential microbiological contamination (e.g., viral, bacterial or prion) has been separately reviewed by the review programme responsible for biological drugs. The issues relating to microbiological contamination were satisfactorily addressed. The quality (chemistry and manufacturing) component of this submission was assessed and found to meet required standards. The data to support the qualification of potential impurities have been evaluated by the clinical bureau and found to be acceptable.
Desflurane Liquid for Inhalation by Blue-Zone Technologies Ltd. is to be available in 250 mL polyvinyl chloride-coated amber glass bottles containing 180 mL of liquid Desflurane. The bottles are to be co-packaged with a screw-on bottle adapter. Sufficient data were provided to demonstrate the acceptability of the delivery system.
The drug substance and drug product are manufactured in a consistent manner. Blue-Zone Technologies Ltd. has adopted relevant and appropriate controls to ensure the quality of the final drug product.
This ANDS for Desflurane by Blue-Zone Technologies Ltd. is considered to meet the requirements of the Food and Drug Regulations. On the basis of the data submitted, this product was granted authorization.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| DESFLURANE | 02498146 | BLUE-ZONE TECHNOLOGIES LTD | DESFLURANE 100 % / V/V |